A Prospective, Multi-center, Randomized Controlled Study Evaluating the Efficacy and Safety of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision
Phase: NA
Conditions: Sutures
Sponsor: Ethicon, Inc.

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
1 
ESC-201702 
A Prospective, Multi-center, Randomized Controlled 
Study Evaluating the Efficacy and Safety of Two Types 
of Absorbable Surgical Sutures in the Suturing of 
Thyroid Surgery Incision 
 
Name of 
investigational 
medical device 
1. Absorbable Surgical Suture（
 
 
 Knotless Tissue Control Device） 
2. Absorbable Surgical Suture（
 
 Knotless Tissue Control Device） 
Model/Specifica
tion 
See Appendix 
Management 
category of 
investigational 
medical device 
Class III medical device that needs the approval for clinical 
trial   Y   N□
√E  
Similar product in same category in China    Y    NA□
√E  
Protocol version 
number 
V2.0 
Protocol version 
date 
2019-09-30 
Clinical trial 
institution 
The 
 
Investigator 
 
Sponsor 
 LLC 
Agent 
 
 
This study protocol contains the confidential information for the use of clinical investigators only. This 
document remains the exclusive property of the 
. The undisclosed 
information herein should not be disclosed without the prior written approval of 
 
. This document is only for the use of interested parties. 
 
 
 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
2 
 
Revision Record 
Revised 
version 
Revision date 
Description of changes 
2.0 
Sep 30 2019 
 
1. 7.2.1 Flow diagram of clinical trial： 
Project/Withdraw visit     
Event/time point/Discharge or after ICF 
withdrawal 
h. Including incisional wound separation or 
wound dehiscence requiring intervention, 
target incisional wound healing delay, etc. 
For subjects who are randomized but without 
any of study sutures used for incision 
closure, this visit is conducted at discharge. 
For subjects who withdraw ICF, this visit is 
conducted as early as possible with subjects’ 
permission. Telephone visit is acceptable. 
 
Changed to： 
Project/Withdraw visit  
Event/time point/For subjects randomized but 
without any of study sutures used and for 
subjects who withdraw ICF i 
h. Including incisional wound separation or 
wound dehiscence requiring intervention, 
target incisional wound healing delay, etc. 
i. For subjects who are randomized but 
without any of study sutures used for 
incision closure, this visit is conducted as 
early as possible. For subjects who withdraw 
ICF, this visit is conducted as early as 
possible with subjects’ permission. 
Telephone visit is acceptable. 
 
2. 7.2.3 Study Procedures 
6) Withdraw visit – Discharge or after ICF 
withdrawal  
For subjects who are randomized but without 
any of study sutures used for incision 
closure, this visit is conducted at discharge. 
For subjects who withdraw ICF, this visit is 
conducted as early as possible with subjects’ 
permission. Telephone visit is acceptable. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
3 
 
Changed to： 
6) Withdraw visit –For subjects randomized 
but without any of study sutures used and for 
subjects who withdraw ICF  
For subjects who are randomized but without 
any of study sutures used for incision 
closure, this visit is conducted as early as 
possible. For subjects who withdraw ICF, this 
visit is conducted as early as possible with 
subjects’ permission. Telephone visit is 
acceptable. 
 
3. 8.8 Selection Criteria and Reason of Subjects 
Included in the Analysis: 
PP (evaluable) Set contains all the subjects in 
the FAS who have no major protocol 
deviation and have data available for primary 
efficacy endpoint and do not meet any of the 
following criteria: 
 o Intraoperative use of other auxiliary 
incision(s) at the neck or combination with 
other surgical procedures except 
thyroidectomy (except the dissection of 
lymph nodes in the VI area); 
 
Changed to：  
PP (evaluable) Set contains all the subjects 
in the FAS who have no major protocol 
deviation, have data available for primary 
efficacy endpoint and do not meet any of the 
following criteria: 
 o Subject undergoes any of the following 
procedures, in addition to thyroidectomy： 
1、 
Any surgical procedure which require 
additional neck incisions or extend the 
original incision; 
2、 
Cervical lymph node dissection (except the 
dissection of lymph nodes in the VI area); 
3、 
Other unplanned surgical procedures 
(except the procedure that the  
investigator doesn’t think it will affect the 
original incision’s healing) 

 LLC
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
4 
TABLE OF CONTENTS  
 
Abbreviations ........................................................................................................ 8 
Synopsis ................................................................................................................ 9 
1. Sponsor Information ........................................................................................ 13 
2. List of Clinical Trial Institutions and Investigators ........................................... 13 
3. Objective and Contents of Clinical Trial ........................................................... 13 
3.1 Objective of Clinical Trial .......................................................................... 13 
3.2. Contents of the Clinical Trial ..................................................................... 13 
4. Background Information of Clinical Trial ......................................................... 14 
4.1 Introduction to the Condition and Investigational Products ............................ 14 
4.2 Application of Investigational Products and Control Products ........................ 15 
4.3 Product Registration and Reason for Clinical Trial Registration in China ........ 15 
5. Features, Structural Composition, Operation Principle, Mechanism of Action, 
and Study Population ........................................................................................... 15 
5.1 Features ................................................................................................... 15 
5.2. Structural Composition, Operation Principle, Mechanism of Action .............. 16 
5.3 Study Population ....................................................................................... 16 
6. Indications and Contraindications, Precautions ................................................ 16 
6.1 
: ....................................................................................... 16 
6.2 
: .......................................................................... 17 
7. Overall Design ................................................................................................. 18 
7.1 Trial Design ............................................................................................. 18 
7.1.1. Trial Objective .......................................................................................................................... 18 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
5 
7.1.2 Trial Method Selection and Its Rationale ................................................................................... 18 
7.1.3 Measures to Reduce and Avoid Bias ......................................................................................... 18 
7.1.4 Investigational Medical Devices and Control Medical Devices ................................................ 19 
7.1.5 Subject Selection ........................................................................................................................ 20 
7.1.6 Efficacy Evaluation Method ...................................................................................................... 22 
7.1.7 Safety Evaluation Method .......................................................................................................... 23 
7.2 Trial Flow Chart ....................................................................................... 24 
7.2.1 Flow diagram of clinical trial ..................................................................................................... 24 
7.2.2 Specifications for Use of Devices .............................................................................................. 26 
7.2.3 Study Procedures ....................................................................................................................... 29 
7.3 Monitoring Plan ........................................................................................ 33 
8 Statistical Considerations .................................................................................. 34 
8.1 Statistical Design, Method and Analysis Procedure ....................................... 34 
8.2 Calculation of Sample Size ........................................................................ 35 
8.2.1 Total Sample size ....................................................................................................................... 35 
8.2.2 Number of Subjects for Clinical Trial of Each Disease Entity and Reasons for Determination 35 
8.2.3 Minimum and Maximum Number of Subjects in Each Clinical Trial Institution and Reasons for 
Determination ..................................................................................................................................... 36 
8.3 Significance Level and Power of Clinical Trial ............................................. 36 
8.4 Expected Dropout Rate .............................................................................. 36 
8.5 Criterion of Acceptability/Unacceptability of Clinical Trial Result ................. 36 
8.6 Criteria and Reason for Terminating the Trial Based on the Statistical Results . 36 
8.7 Statistical Method of All Data, together with the Handling Method of Missing, 
Unused and Error Data (including Termination and Withdrawal Halfway) and 
Unreasonable Data .................................................................................. 36 
8.8 Selection Criteria and Reason of Subjects Included in the Analysis ................ 36 
8.9 Special Information Excluded during Hypothesis Testing and Justification (If 
Applicable) ............................................................................................. 37 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
6 
9. Data Management ............................................................................................ 37 
10. Feasibility Analysis ......................................................................................... 37 
10.1 Feasibility analysis of success................................................................... 37 
10.2 Feasibility analysis of Failure ................................................................... 38 
11. Quality Control of Clinical Trials .................................................................... 38 
12. Clinical Trial-Involved Ethical Issues and Informed Consent .......................... 38 
12.1 Ethical Concerns ..................................................................................... 38 
12.2 Approval of Trial Protocol ........................................................................ 39 
12.3 Process of Informed Consent and Text of Informed Consent Form ............... 39 
12.3.1 Process of informed consent .................................................................................................... 39 
12.3.2 Text of Informed Consent Form .............................................................................................. 40 
13. Device Management ....................................................................................... 40 
13.1 Accountability of investigational devices ................................................................................... 40 
13.2 Return of investigational devices ................................................................................................ 40 
14. Regulations of Adverse Event And Device Complaint Reporting ...................... 40 
14.1 Adverse Event ......................................................................................... 40 
14.2 Serious Adverse Event ............................................................................. 41 
14.3 Device Complaints .................................................................................. 41 
14.4 Device Defects ........................................................................................ 41 
14.5 Reporting Procedure and Contact Person Information ................................. 42 
15. Deviation From Clinical Trial Protocol And Regulations For Clinical Trial 
Protocol Amendment ........................................................................................... 43 
16. Direct Access to Source Data and Document ................................................... 43 
17. Finances And Insurance ................................................................................. 44 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
7 
18. Contents Should Be Covered By Clinical Study Report ................................... 44 
19. Confidentiality Principle ................................................................................. 44 
20. Agreement On The Publication of Trial Results ............................................... 45 
21. Responsibilities That Each Party Should Bear ................................................ 45 
21.1 Sponsor Responsibility ............................................................................ 45 
21.2 Responsibilities of Clinical Trial Institution and Investigator ....................... 45 
21.3 Responsibilities of other interested parties ................................................. 46 
Statement of Investigator ..................................................................................... 47 
Annex 1: References ............................................................................................ 48 
Annex 2: List of Specifications and Models ........................................................... 50 
Annex 3: Modified Hollander Wound Evaluation Scale ........................................ 53 
Annex 4: Vas Scale ............................................................................................... 54 
Annex 5: EQ-5D-5L ............................................................................................. 55 
Annex 6: Asepsis Score (Example) ........................................................................ 58 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
8 
 Abbreviations 
Acronyms / Abbreviations 
Terms 
ACP 
Acyl carrier protein 
ACS 
American College of Surgeons 
AE 
Adverse event 
CDC 
Centers for Disease Control and Prevention 
CRO 
Contract Research Organization 
EC 
Ethics Committee 
EMS 
Express Mail Service 
EQ-5D-5L 
European Quality of Life-5 Dimensions, 5 Levels Scale 
e-CRF 
Electronic Case Report Form 
FAS 
Full analysis set 
FPG 
Fasting plasma glucose 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
LLC 
Limited Liability Company 
 
 
 
 
PP 
Per Protocol 
SAE 
Serious adverse event 
SOP 
standard operating procedure 
SSI 
Surgical site infection 
VAS 
Visual Analogue Scale 
WHO 
World Health Organization 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
9 
Synopsis 
Study Title 
A Prospective, Multi-center, Randomized Controlled Study 
Evaluating the Efficacy and Safety of Two Types of Absorbable 
Surgical Sutures in the Suturing of Thyroid Surgery Incision 
Study Objective 
The primary objective of this study is to evaluate the efficacy and 
safety of two types of absorbable surgical sutures -- 
 Knotless Plus Tissue Control 
Device and 
 
Knotless Tissue Control Device (hereinafter referred to as 
 
 and 
) used in thyroid surgery 
to suture surgical incision. 
Number of Study 
Sites 
Planned selection of 10 sites 
Number of 
subjects 
Planned enrollment of 501 subjects 
Study Design 
This study adopts a multicenter, prospective, randomized 
controlled design. The study population are subjects who undergo 
thyroid surgery. 
Before the surgery, subjects are randomized in 1:1:1 ratio to the 
investigational group 1 (using 
), investigational 
group 2 (using 
) and control group. See 
the table below for the specific suture levels, materials and 
techniques of each group. 
Level 
Suture Material (Technique) 
Investigational 
group 1 
Investigational 
group2 
Control 
group 
Ribbon 
muscles 
 
 
(Continuous) 
 
(Continuous) 
 
(Continuous) 
Platysma 
 
(Interrupted) 
Intradermal 
 
(Continuous) 
 
(Continuous) 
 
(Continuous) 
A blinded central imaging evaluation will be performed on the 
healing condition of surgical incision on Day 5-7 post-surgery. 
The subjects will be blinded to the type of suture used for wound 
closure. 

LLC
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
10 
Study Device 
 absorbable surgical suture is an antibacterial 
monofilament, synthetic absorbable device consisting of dyed 
(violet) polyester, i.e. poly(p-dioxanone), the empirical 
molecular formula of which is (C4H6O3)X. As the device is 
designed with barbs, it allows tissue approximation without the 
need to tie surgical knots. The device contains IRGACARE® 
MP (triclosan), a broad spectrum antibacterial agent, at no more 
than 2,360 μg/m. The pigment for the violet dye is D&C Violet 
No.2. Polydioxanone polymer has been found to be 
nonallergenic, nonpyrogenic and elicits only a slight tissue 
reaction during absorption. 
 absorbable surgical suture is an 
antibacterial monofilament, synthetic absorbable device 
prepared from a copolymer of glycolide and ε-caprolactone 
(Poliglecaprone 25). As the device is designed with barbs, it 
allows tissue approximation without the need to tie surgical 
knots. The device contains IRGACARE® MP (triclosan), a 
broad spectrum antibacterial agent, at no more than 2,360 μg/m. 
Poliglecaprone 25 copolymer has been found to be 
nonpyrogenic and elicits only a slight tissue reaction during 
absorption. 
Inclusion Criteria 
Subjects will be included if ALL of the following inclusion 
criteria applies: 
1) The subject is ≥18, and <70 years old 
2) Planned open thyroid surgery, adopting an anterior 
cervical curved incision (Kocher’s incision); 
3) Subject who volunteers to participate in this study, 
follows the study requirements and follow-up visit and 
signs the written Informed Consent Form voluntarily; 
4) Subject who agrees to not schedule any elective surgical 
operation except the study surgery before the study is 
completed; 
5) The investigator considers the subject’s expected 
postoperative survival time is not less than 3 months. 
Exclusion Criteria 
Subjects will be excluded if ANY of the following exclusion 
criteria applies: 
1) Female subjects who are pregnant or lactation at 
screening; 
2) Preoperative clinical staging shows stage IV thyroid 
cancer, or cervical lymph nodes dissection is planned; 
3) Suspected or confirmed anaplastic thyroid cancer; 
4) Peripheral vascular disease affecting blood supply of the 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
11 
neck; 
5) Active infectious collagenosis (e.g. scleroderma), or any 
other disease that would interfere with wound healing; 
6) Fasting plasma glucose ≥7.7 mmol/L; 
7) History of coagulation diseases; 
8) Current oral or intravenous antibiotic therapy for existing 
disease or infection; 
9) History of immunosuppressant use (e.g. steroids) within 
the last 6 months; 
10) Chemotherapy or radiotherapy within the last 6 months, 
or planned chemotherapy or radiotherapy during the 
study; 
11) Personal or family history of keloid formation or 
hyperplasia; 
12) Current participation in any other drug (within 30 days or 
within 5 half-lives of the investigational drug) or device 
clinical study; 
13) History of any thyroid surgery, except thyroid fine-needle 
aspiration biopsy; 
14) Planned use of skin adhesive at the incision site; 
15) The subject is not suitable for participating in this study 
for any other reasons, as judged by the investigator. 
Endpoints 
Primary Efficacy Endpoint: Proportion of subjects achieving 
Grade A healing of surgical incision(success) in each group. 
Wound healing grade will be assessed by independent, blinded 
Central Imaging evaluators using (a picture of complete neck 
anterior view, containing full length of the incision) on Day 5-
7 post-surgery. 
 
Secondary Efficacy Endpoints: 
1. Incision suturing time, defined as the time required from the 
first needle insertion for stitching ribbon muscles to the 
completion of intradermal suture (min) 
2. Modified Hollander Wound Evaluation Scale [assessed by 
Central Imaging evaluators using pictures, including a 
picture of complete neck anterior view containing full length 
of the incision, a picture taken parallel to the incision plane, 
a picture taken at a 45° angle to the incision plane, and 
incision lateral view pictures of both sides (one for each)]; 
3. Postoperative incision pain score (Visual Analogue Scale, 
VAS); 
4. Health related quality of life scale (EQ-5D-5L). 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
12 
Safety Endpoints include: 
1. Incidence of postoperative surgical site infection (SSI); 
2. ASEPSIS score (only assessed in subjects with confirmed 
SSI); 
3. Incidence of incisional wound separation or wound 
dehiscence requiring intervention; 
4. Incidence of delayed incisional wound healing events; 
5. Incidence of other adverse events; 
6. Product complaints. 
 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
13 
1. Sponsor Information 
(1) Name of Sponsor 
 LLC 
(2) Address of Sponsor 
 
(3) Contact of Sponsor 
Contact: 
 
Tel: 001 
 
E-mail: 
 
Address: 
 
(4) Related qualification documents of Sponsor: 
Related qualification documents of sponsor included (ISO 13485 certificate, 510K certificate about 
the product’s marketing in USA). See related documents. 
(5) Name, address, contact and related qualification documents of agent: 
 
. 
E-mail:
 
Tel:
 
. 
Related qualification documents of agent include (company business license, medical device 
business license). See related materials 
 
2. List of Clinical Trial Institutions and Investigators 
See related materials. 
 
3. Objective and Contents of Clinical Trial 
3.1 Objective of Clinical Trial 
The primary objective of this study is to evaluate the efficacy and safety of two types of 
absorbable surgical sutures -- 
 Knotless Plus Tissue Control 
Device and 
 Plus Knotless Tissue Control Device 
(hereinafter referred to as 
 and 
) used in thyroid 
surgery to suture surgical incision. 
3.2. Contents of the Clinical Trial 
This study is designed to be a three-arm, prospective, multicenter, randomized controlled study, 
comparing the efficacy (non-inferiority tests) and safety of 
 and 
 
 with the control group (
 with 
) in soft tissue 
suturing. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
14 
The study population includes 501 cases of subjects who plan to receive thyroid surgery. The 
subjects are randomized into the investigational group 1 (using 
), investigational 
group 2 (using 
) and control group (using 
 and 
 
 according to the ratio of 1:1:1. See the table below for the specific suture levels, materials 
and techniques of each group. 
Level 
Suture Material (Technique) 
 
Investigational 
group 1 
Investigational group2 
Control group 
Ribbon 
muscles 
 
(Continuous) 
 
(Continuous) 
 
(Continuous) 
Platysma 
 
(Interrupted) 
Intradermal 
 
(Continuous) 
 
(Continuous) 
 
(Continuous) 
The above subjects will be followed up on Day 5-7 and Day 28-35 post-surgery, respectively. 
The primary endpoint is the proportion of subjects achieving Grade A healing of surgical 
incision in each group, central blinded evaluation will be performed on the incision pictures 
taken on Day 5-7 post-surgery; secondary endpoints include: incision suturing time, modified 
Hollander Wound Evaluation Scale, postoperative incision pain score, health related quality of 
life scale; safety endpoints include: incidence of postoperative surgical site infection (SSI), 
ASEPSIS score, incidence of incisional wound separation or wound dehiscence requiring 
intervention, incidence of delayed incisional wound healing events, incidence of other adverse 
events (AE), and product complaints.  
 
4. Background Information of Clinical Trial 
4.1 Introduction to the Condition and Investigational Products 
Thyroid surgery is a very common type of wound cleaning surgery and with the development 
of surgical techniques and continuous improvement in people’s pursuit of beauty, patients pay 
more and more attention to the appearance of incision after thyroid surgery. Surgeons have to 
choose appropriate surgical incision and approach, suture technique and material, minimize 
damage at different anatomical layers, reduce incision scar, decrease penetrance of scar and 
improve patients’ quality of life, on the condition that the quality of thyroid surgery is 
guaranteed. At present, from the perspective of surgical approach, thyroid surgery is mainly 
done via open and endoscopic approaches and if an open surgery is done, an anterior cervical 
curved incision (Kocher’s incision) is mainly adopted, while other incisions are not as 
commonly used as before. Since open thyroid surgery has a big base, there has been certain 
consensus on the use of intradermal continuous suture to reduce penetrance of scar clinically, 
and therefore the anterior cervical curved incision is selected for the thyroid surgery in this 
study. 
In this study, the investigational products are two types of absorbable surgical sutures, and 
compared to traditional sutures, these two sutures are both knotless, surgical sutures containing 
an antibacterial agent (triclosan), except one of them consists of poly(p-dioxanone) and another 
is prepared from a copolymer of glycolide and ε-caprolactone.  
The knotless function of the investigational products is realized by forming barbs via cutting 
the suture body, and such a design has been extensively applied in knotless sutures and has been 
demonstrated to be qualified for wound stitching (including high tensile tissues) and to reduce 
surgery (suture) time by lots of clinical studies and literature [1-5]. Besides, the decrease in 
surgery time is also related to the reduction of wound complications, especially SSI [6]. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
15 
In addition, the investigational product also contains an antibacterial agent to resist SSI 
(nonantibacterial launched products have been marketed in China). The antibacterial agent 
contained is triclosan, which, at a low concentration, can interact with the acryl carrier protein 
(ACP) reductase (FabI) of sensitive bacteria and subsequently inhibit the formation of sensitive 
bacterial fatty acids to achieve an antibacterial effect [7]. It has been confirmed both in in vivo 
and in vitro experiments that, triclosan-containing sutures can effectively resist colonization of 
sensitive bacteria, including Staphylococcus aureus, Staphylococcus epidermidis, methicillin-
resistant Staphylococcus aureus, methicillin-resistant Staphylococcus epidermidis, Klebsiella 
pneumoniae and Escherichia coli [8-10]. In the meantime, it has also been shown by clinical 
studies that, such an effect also works in human body to reduce about 30% of SSIs [11-12]. Based 
on the great clinical efficacy and safety in clinical application of such sutures, World Health 
Organization (WHO), American College of Surgeons and US Centers for Disease Control and 
Prevention (CDC) all recommend the application of knotless sutures in surgeries to prevent SSI 
in their guidelines [13-15]. 
To sum up, the investigational products will be new products with two kinds of relatively 
mature suture processes applied in the same type of suture. This study will demonstrate the 
investigational products’ efficacy in wound closure in thyroid surgery and safety in clinical 
application, to support the marketing of the products in China. 
4.2 Application of Investigational Products and Control Products 
The investigational products have been granted with 510K clearance by the country of origin USA 
in 2015. Currently the products have been marketed in many countries, however, due to the short 
marketing time, they have not been reported in literature yet. 
Both the control products
 and 
 are non-barbed, triclosan-coated sutures. 
Such sutures have been marketed in China since 2014. As mentioned above, the efficacy and safety 
of such sutures have been sufficiently validated [11-12, 16]. 
4.3 Product Registration and Reason for Clinical Trial Registration in China 
The investigational products were granted with 510K marketing clearance by the country of 
origin USA in 2015 and was granted with EU marketing authorization (CE certificate) in 2016. 
To support the marketing of the investigational products in China and according to the requirements 
of China’s Guidelines for Medical Evaluation of Medical Devices, the study selects non-barbed 
 
 and 
 as launched products. The difference between the investigational 
products and launched products lies in whether they contain barbs or not. Therefore, the clinical 
trial design is to demonstrate that the barbed nature of the suture does not have any adverse impact 
on the safety and efficacy of the products. 
 
5. Features, Structural Composition, Operation Principle, Mechanism of Action, 
and Study Population 
5.1 Features 
Type 
Name 
of 
device 
Design Features 
Characteristics 
of 
Material 
Investigational 
Product 1 
 
 This 
product 
is 
an 
antibacterial 
monofilament 
absorbable 
suture 
consisting of barbed suture material. Its 
barbs allow tissue approximation without 
the need to tie surgical knots. The suture 
contains triclosan, an antibacterial agent, 
which is only used to inhibit colonization 
of bacteria on sutures. 
The suture material 
is 
polyester, 
i.e. 
poly(p-dioxanone), 
the 
empirical 
molecular formula 
of 
which 
is 
(C4H6O3)x. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
16 
Investigational 
Product 2 
 
 
This 
product 
is 
an 
antibacterial 
monofilament absorbable suture prepared 
from barbed suture material. Its barbs 
allow tissue approximation without the 
need to tie surgical knots. The suture 
contains triclosan, an antibacterial agent, 
which is only used to inhibit colonization 
of bacteria on sutures. 
The suture material 
is prepared from 
Poliglecaprone 25 
(i.e. a copolymer of 
glycolide and ε-
caprolactone). 
5.2. Structural Composition, Operation Principle, Mechanism of Action 
The study products are both absorbable surgical sutures armed with a surgical needle to suture 
soft tissues. The study products contain a fixation loop and barbs to anchor tissues and do not 
require knots to secure the device. The sutures contain triclosan, am antibacterial substance that 
is only used to inhibit colonization of bacteria on sutures. 
Using the 
 suture in sizes 3-0 or larger, approximately 80% of its original 
strength remains after at two weeks and four weeks of implantation. At six weeks post 
implantation, approximately 40% to 70% of its original strength is retained. For size 4-0, 
approximately 67% of its original strength remains after two weeks, and approximately 50% at 
four weeks of implantation. At six weeks post implantation, approximately 37% of its original 
strength is retained. Data obtained from implantation studies show the absorption of 
 
 suture is essentially complete within 210 days. Using the 
 suture, 
approximately 62% of its original tensile strength remains after 7 days implantation; and 
approximately 27% of its original tensile strength at 14 days post implantation. All of the 
original tensile strength is lost by 21 days post implantation. The absolute strength remaining 
14 days post implantation meets or exceeds that historically observed with plain or chromic 
surgical gut devices. Data obtained from implantation studies show that absorption of 
 
 suture is essentially complete by 91 days. 
The product schematic diagram is as follows: 
Unidirectional barbs 
Bidirectional barbs 
Artificial synthetic absorbable sutures are used to temporarily align edges of wound, until it is 
fully healed and able to withstand normal stress. It design is armed with predictable degradation 
and absorption rates. 
5.3 Study Population 
This clinical study will include subjects who undergo thyroid surgery via an anterior cervical 
arch incision (Kocher’s incision). 
 
6. Indications and Contraindications, Precautions 
6.1 
: 
[Indication]: It is indicated for use in soft tissue approximation where the use of absorbable 
sutures is appropriate. 
[Contraindications]: It is not to be used where prolonged (beyond six weeks) approximation of 
tissues under stress is required and is not be used for fixation of or in conjunction with prosthetic 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
17 
devices (e.g. heart valves or synthetic grafts) that are nonabsorbable in nature. This device, 
being absorbable, should not be used where extended approximation of tissue under stress is 
required, such as in fascia. The device should not be used in patients with known allergic 
reactions to IRGACARE®* MP (triclosan). 
[Precautions]: The device contains a fixation loop and barbs to anchor tissues and do not 
require knots to secure the device. Tying of knots on the barbed section of the device will 
damage the barbs and potentially reduce their efficacy. For the device to function properly, the 
device must first be anchored in robust tissue using the fixation loop. Then subsequently engage 
the barbs into the tissue in a standard closure pattern. When completing placement of the barbed 
segment in subcuticular tissue, take at least one additional pass in the reverse direction to lock 
the device in place. In all other tissue layers, take at least two passes in the reverse reaction to 
lock the device in place. 
Avoid contacting the device with other materials (e.g. surgical gauze, drapes, etc.) in the 
surgical field to prevent ensnaring on the barbs. If the barbs catch, carefully pull the material in 
the opposite direction of the needle to disengage it from barbs. 
When using the device subcutaneously, the device should be placed as deeply as possible in 
order to minimize erythema and induration normally associated with absorption. 
Care should be taken to avoid damage when handling the device. Avoid crushing or crimping 
the suture material with surgical instruments (e.g. needle holders or forceps). Do not attempt to 
remove memory in the polymer by running fingers down the suture material as this can damage 
the barbs. 
Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare 
instances wound separation are typical or foreseeable risks associated with any suture and hence 
are also potential complications associated with the device. 
Acceptable surgical practice should be followed with respect to drainage and closure of infected 
wounds. To avoid damaging needle points and swage areas, grasp the needle in an area one-
third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles 
may cause them to lose strength and be less resistant to bending and breaking. Users should 
exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard 
used needles in designated biohazard “sharps” containers. 
Store at or below 30℃. 
6.2 
: 
[Indication]: It is indicated for use in soft tissue approximation where the use of absorbable 
sutures is appropriate. 
[Contraindications]: It is not to be used where prolonged approximation of tissues under stress 
is required and is not be used for fixation of or in conjunction with prosthetic devices (e.g. heart 
valves or synthetic grafts) that are nonabsorbable in nature. This device, being absorbable, 
should not be used where extended approximation of tissue under stress is required, such as in 
fascia. The device should not be used in patients with known allergic reactions to 
IRGACARE®* MP (triclosan). 
[Precautions]: The device contains a fixation loop and barbs to anchor tissues and do not 
require knots to secure the device. Tying of knots on the barbed section of the device will 
damage the barbs and potentially reduce their efficacy. For the device to function properly, the 
device must first be anchored by using the fixation loop in robust tissue. Then subsequently 
engage the barbs into the tissue in a standard closure pattern. When completing placement of 
the barbed segment in subcuticular tissue, take at least one additional pass in the reverse 
direction to lock the device in place. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
18 
Avoid contacting the device with other materials (e.g. surgical gauze, drapes, etc.) in the 
surgical field to prevent ensnaring on the barbs. If the barbs catch, carefully pull the material in 
the opposite direction of the needle to disengage it from barbs.  
Skin devices that remain in place longer than 7 days may cause localized irritation and should 
be snipped off or removed if indicated. Subcuticular devices should be placed as deeply as 
possible to minimize the erythema and induration normally associated with absorption 
Under some circumstances, notably orthopedic procedures, immobilization of joints by external 
support may be employed at the discretion of the surgeon. Consideration should be taken in the 
use of absorbable devices in tissue with poor blood supply as device extrusion and delayed 
absorption may occur. In handling this or any other device material, care should be taken to 
avoid damage from handling. 
Avoid crushing or crimping damage due to application of surgical instruments (e.g. forceps or 
needle holders). Do not attempt to remove memory in the polymer by running fingers down the 
suture material as this can damage the barbs. 
Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare 
instances wound separation are typical or foreseeable risks associated with any suture and hence 
are also potential complications associated with the device. 
Acceptable surgical practice should be followed with respect to drainage and closure of infected 
wounds. To avoid damaging needle points and swage areas, grasp the needle in an area one-
third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles 
may cause them to lose strength and be less resistant to bending and breaking. Users should 
exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard 
used needles in “sharps” containers. 
Store at or below 30℃. 
7. Overall Design 
7.1 Trial Design 
7.1.1. Trial Objective 
The primary objective of the study is to evaluate the of 
 or 
 
 in thyroid surgery to suture surgical incision. 
7.1.2 Trial Method Selection and Its Rationale 
According to the regulatory requirements of the Guidelines for Technical Review of Absorbable 
Surgical Suture Registration, a prospective, randomized controlled design should be adopted to 
compare the investigational device with launched product. Therefore, this study adopts a 
prospective, multicenter, randomized controlled trial design. 
7.1.3 Measures to Reduce and Avoid Bias 
In the study, central randomization will be adopted to randomly assign eligible subjects to one 
of the three groups: investigational group 1, investigational group 2 or control group according 
to the same inclusion/exclusion criteria to reduce the impact caused by unknown confounding 
factors and avoid selection bias.  
Study blinding is as follows: 
o 
Subject: Subjects are informed prior to surgery that they will be randomized to any of the 
study groups with equal probability, and during the surgery, a blinding method will be 
adopted for them. 
o 
Investigator responsible for incision suture: Considering the investigational groups and 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
19 
control group use different shapes and usages of suture, it is impossible to blind 
investigators who are responsible for suturing. 
o 
Central evaluator: Imaging data will be submitted to Imaging Center for assessment to 
assess the primary endpoint and the modified Hollander score among secondary endpoints. 
The Central Imaging evaluators will be blinded. 
o 
Monitor: As the product information is specified on the detachable label supplied with the 
product and instrument counting and source document verification is - done with the study 
product inventory records and subject’s medical record, the monitor will not be blinded. 
 In addition, this study will collect data about objective measures, study related information 
will be recorded in the source medical records as detailed as possible, the monitor will pay 
attention to verifying the data in the source medical records during the monitoring process, 
investigator training will be strengthened, and investigators will closely communicate with 
subjects to improve compliance of subjects. This will help to reduce the informational bias. 
7.1.4 Investigational Medical Devices and Control Medical Devices 
 
Investigational 
Device 1 
Investigational
Device 2 
 
 
 
Control Device 
 or 
 
Picture 
Launch 
the 
global market 
(year) 
Global: 2016 
Global: 2016 
Global: 2006 
China: 2014 
Indications 
Indicated 
for 
use 
in 
soft 
tissue 
approximation 
where the use 
of absorbable 
sutures 
is 
appropriate 
Indicated 
for 
use 
in 
soft 
tissue 
approximation 
where the use 
of absorbable 
sutures 
is 
appropriate 
: Indicated for use in soft tissue 
approximation, including use in pediatric 
cardiovascular tissue where growth is 
expected to occur and ophthalmic surgery 
(other than contact with cornea and sclera). 
 suture is not indicated in adult 
cardiovascular tissue, microsurgery and 
neural tissue. These sutures are particularly 
useful where the combination of an 
absorbable suture and extended wound 
support (up to six weeks) is desirable. 
: Indicated for use in 
general soft tissue approximation and/or 
ligation, but not for use in cardiovascular or 
neurological 
tissues, 
microsurgery 
or 
ophthalmic surgery. 
Components 
Suture, 
surgical needle 
Suture, 
surgical needle 
Suture, surgical needle 
Size 
4-0 to 1 
 
4-0 to 2-0 
:6-0 to 1 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
20 
:6-0 to 1 
Materials 
Poly(p-
dioxanone) 
 
Poliglecaprone 
25 (i.e. a 
copolymer of 
glycolide and 
ε-
caprolactone) 
: Poly(p-dioxanone) 
:Poliglecaprone 25 (i.e. a 
copolymer of glycolide and ε-caprolactone) 
7.1.5 Subject Selection 
1) Inclusion criteria 
1. 
The subject is ≥18, and <70 years old 
2. 
Planned open thyroid surgery, adopting an anterior cervical curved incision (Kocher’s incision); 
3. 
Subject who volunteers to participate in this study, follows the study requirements and follow-
up visit and signs the written Informed Consent Form voluntarily; 
4. 
Subject who agrees to not schedule any elective surgical operation except the study surgery 
before the study is completed; 
5. 
The investigator considers the subject’s expected postoperative survival time is not less than 3 
months. 
2) Exclusion Criteria 
1. 
Female subjects who are pregnant or lactation at screening; 
2. 
Preoperative clinical staging shows stage IV thyroid cancer, or cervical lymph nodes dissection 
is planned; 
3. 
Suspected or confirmed anaplastic thyroid cancer; 
4. 
Peripheral vascular disease affecting blood supply of the neck; 
5. 
Active infectious collagenosis (e.g. scleroderma), or any other disease that would interfere with 
the wound closure; 
6. 
Fasting plasma glucose (FPG) ≥7.7 mmol/L; 
7. 
History of coagulation diseases; 
8. 
Current oral or intravenous antibiotic therapy for existing disease or infection; 
9. 
History of immunosuppressant use (e.g. steroids) within the last 6 months; 
10. Chemotherapy or radiotherapy within the last 6 months, or planned chemotherapy or 
radiotherapy during the study; 
11. Personal or family history of keloid formation or hyperplasia; 
12. Current participation in any other drug (within 30 days or within 5 half-lives of the 
investigational drug) or device clinical study; 
13. History of any thyroid surgery, except thyroid fine-needle aspiration biopsy; 
14. Planned use of skin adhesive at the incision site; 
15. The subject is not suitable for participating in this study for any other reasons, as judged by the 
investigator. 
3) Criteria and procedure of Study Discontinuation  
The criteria for Subject’s Discontinuation from Study include, but are not limited to:  
1. 
Withdrawal of consent: Subject decides to withdraw from the study. This decision must be 
“self-determination” and should be documented; 
2. 
Investigator’s judgement: The Investigator may determine the withdrawal of subjects from the 
study according to reasonable medical judgement and such withdrawal may benefit the subject 
mostly. 
3. 
Adverse event (AE)/Serious Adverse event (SAE: The AE or SAE may not cause the subjects 
to discontinue the study treatment. If the investigator decides to withdraw a subject from the 
study, this subject must be followed up, until the AE/SAE is resolved or until the stable clinical 
endpoint is reached; 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
21 
4. 
Subject died; 
5. 
Lost to follow-up: All subjects should be able to participate in all scheduled visits, providing 
the appropriate contact information. If a subject can’t return to undergo the scheduled clinical 
visit, attempts to contact the subject by phone should be done 3 times to ask the subject to 
participate in all scheduled visits. Each attempt to contact should be recorded in the source 
document. If the subject fails to respond to all three telephone contact attempts, the Investigator 
must send a registered mail or Express Mail Service (EMS) . If the subject fails to respond to 
the registered mail or EMS and makes no further contact, the subject is considered lost-follow-
up and the eCRF at the end of study must be completed; 
6. 
The Sponsor discontinues the study; 
7. 
The health regulatory agency requests discontinuation of the study. 
Procedure for subject’s discontinuation from the trial: 
Subjects should stay in this study until the 28-35day follow-up visit defined in the study 
protocol is completed. If a subject withdraws from this study prematurely, the reason for 
withdrawal must be recorded in the source record and the investigational study file will be 
submitted via e-CRF. 
Subjects who are withdrawn from the study early will be included in the analysis of results; 
however, no new subjects will be recruited to replace the subjects withdrawn from the study. 
Criteria of Sponsor’s Discontinuation of the Trial: 
The Sponsor has the right to terminate the study early for a single site, multiple sites or all sites 
temporarily or permanently. Reasons may include but are not limited to: safety issue or ethical 
issue, inaccurate or incomplete data record, non-compliance or dissatisfactory quality of the 
study recruitment. 
Flow of Sponsor’s Discontinuation of the Trial: 
When deciding to suspend or terminate the clinical trial, the Sponsor should inform all the 
clinical trial institutions and medical device clinical trial regulatory departments and give 
written explanations. The clinical trial institutions and medical device clinical trial regulatory 
departments should inform corresponding investigators and ECs timely. A suspended clinical 
trial cannot be restored without the approval of EC. 
4) 
Enrollment 
Subjects will be considered enrolled into the study upon satisfaction of the following criteria: 
• 
Completion of the informed consent process; 
• 
It is determined by the Investigator that the subject meets all inclusion criteria and does 
not meet any exclusion criteria; 
• 
Completion of randomization. 
No procedures related to the study should be conducted prior to signing the informed consent. 
5) Expected overall duration of clinical trial and reasons for determination 
The expected overall duration is approximately 26 months, including the time that each site’s 
Ethics Committee approval, institution contract sign-off, duration of follow-up, time for data 
management, statistical analysis, and time to write the clinical study report. 
6) Expected duration of participation of each subject 
The duration of each subject’s participation in the study will be 28-35 days according to the 
follow-up schedule specified by the protocol. 
7) Number of subjects required for clinical trial 
Approximately five hundred and one (501 subjects will be enrolled in this study, of which 167 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
22 
subjects in investigational group 1, investigational group 2, and control group, respectively. See 
Section 8.2 Calculation of Sample Size for the basis for selecting this sample size. 
7.1.6 Efficacy Evaluation Method 
1) Description of efficacy parameters 
The primary efficacy endpoint is defined as the proportion of subjects achieving Grade A 
healing (success) of surgical incision in each group. 
According to clinical routine practice, wound healing status should be assessed during removal 
of stitches of incision and generally, stitches at the incision of head, face and neck are taken out 
on Day 4-5 post-surgery; however, if energy devices are used (e.g. electrotome), the removal 
of stitches should be delayed by 1-2 days. In this study, all the skin layers can be performed 
with intradermal continuous suture using absorbable sutures, thus it is unnecessary to take out 
stitches at the incision. Therefore, the time of wound healing assessment in this study is set as 
Day 5-7 post-surgery. 
Wound healing status is classified into three grades: 
• 
Grade A healing: Good healing with no adverse reaction; 
• 
Grade B healing: Inflammatory reaction(s) at the healing, such as red swelling, induration, 
hematoma, effusion, etc., but without suppuration; 
• 
Grade C healing: Suppuration of incision, requiring incision and drainage and other 
treatments. 
Secondary Efficacy Endpoints include: 
1. 
Incision suturing time, defined as the time required from the first needle insertion for 
stitching ribbon muscles to the completion of intradermal suture (min); 
2. 
Modified Hollander Wound Evaluation Scale (see Annex 3), assessed by Imaging Center 
evaluators using pictures, including: a picture of complete neck anterior view containing 
full length of the incision, a picture taken parallel to the incision plane, a picture taken at 
a 45° angle to the incision plane, and incision lateral view pictures of both sides (one for 
each); 
3. 
Postoperative incision pain score (VAS scale, see Annex 4-1); 
4. 
Health related quality of life scale (EQ-5D-5L): Subjects are required to select the most 
appropriate levels in 5 aspects to determine their health status (see Annex 5): 
• 
Motility 
• 
Self care 
• 
Daily activities 
• 
Pain/discomfort 
• 
Anxiety/depression 
2) Selection of method and time to evaluate, record and analyze the efficacy parameters 
The primary efficacy endpoint (wound healing grade) will be assessed by independent, blinded 
Imaging Center according to the picture (a picture of complete neck anterior view, containing 
full length of the incision) on Day 5-7 post-surgery and documented in the e-CRF. 
The secondary efficacy endpoints will be documented in the e-CRF according to the 
investigator’s records, Imaging Center evaluator’s assessment records (modified Hollander 
Wound Evaluation Scale) and questionnaires completed by the subject (postoperative incision 
pain score, EQ-5D-5L) and will be collected at V3, V4 and V5. 
See Section 8 for the analysis methods of the above endpoints. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
23 
7.1.7 Safety Evaluation Method 
1) Description of safety parameters 
Safety Endpoints include: 
1. 
Incidence of postoperative SSI, which is defined as follows according the standard of 
US Centers for Disease Prevention and Control [16]: 
1) Superficial incisional SSI: 
Involves skin or subcutaneous tissue, occurs within 30 days postoperatively, and must 
fulfill one of the following additional criteria: 
• 
Purulent drainage from the superficial incision with or without diagnostic laboratory 
testing; 
• 
Microorganisms isolated from aseptically obtained culture of fluid or tissue from the 
superficial incision; 
• 
At least one of the following signs or symptoms of infection: pain or tenderness, 
localized swelling, redness or heat, and the superficial incision is deliberately opened 
by a surgeon (unless culture of incision is negative); 
• 
Diagnosis of a superficial incisional SSI by a surgeon or attending physician. 
Do not report the following conditions as SSI: 
• 
Stitch abscess (minimal inflammation and discharge confined to the points of suture 
penetration); 
• 
Infection of an episiotomy or newborn circumcision site; 
• 
Infected burn wound; 
• 
Incisional SSI that extends into the fascial and muscle layers (see deep incisional SSI). 
Note: Specific criteria are used for identifying episiotomy and newborn circumcision sites 
and infected burn wounds. 
2) Deep incisional SSI: 
Infection occurs within 30 days after the operation if no implant is left in place or within 1 year 
if implant is in place and the infection appears to be related to the operation, infection involves 
deep soft tissues (e.g., fascial and muscle layers of the incision) and at least one of the 
followings: 
• 
Purulent drainage from the deep incision but not from the organ/space component of the 
surgical site; 
• 
A deep incision spontaneously dehisces or is deliberately opened by a surgeon when the 
patient has at least one of the following signs or symptoms: fever (>38°C), localized pain, 
or tenderness, except that the incision is culture-negative; 
• 
An abscess or other evidence of infection involving the deep incision is found on direct 
examination, during reoperation, or by histopathologic or radiologic examination; 
• 
Diagnosis of a deep incisional SSI by a surgeon or attending physician. 
Note: 
• 
Report infection that involves both superficial and deep incision sites as deep incisional 
SSI; 
• 
Report an organ/space SSI that drains through the incision as a deep incisional SSI. 
3) 
Organ/space SSI: 
Infection occurs within 30 days after the operation if no implant is left in place or within 1 year 
if implant is in place and the infection appears to be related to the operation, and infection 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
24 
involves any part of the anatomy (e.g., organs or spaces), other than the incision, which was 
opened or manipulated during an operation, and at least one of the followings: 
• 
Purulent drainage from a drain that is placed through a stab wound into the organ/space; 
• 
Organisms isolated from an aseptically obtained culture of fluid or tissue in the 
organ/space; 
• 
An abscess or other evidence of infection involving the organ/space that is found on direct 
examination, during reoperation, or by histopathologic or radiologic examination; 
• 
Diagnosis of an organ/space SSI by a surgeon or attending physician. 
It is unnecessary to conduct any confirmatory culture, unless the physician considers it 
necessary to provide subjects with appropriate treatment according to the local standard of care. 
2. 
ASEPSIS score (only assessed in subjects with confirmed SSI): 
The severity of incision infection is assessed by numeric scores (determining the presence or 
absence of SSI and types relative to CDC standard). The ASEPSIS incision score is used to 
evaluate the visual characteristics of incision and if additional treatment can be an incentive of 
infection or not when the subject leaves the hospital. The predictors include: serous discharge, 
erythema, purulent exudate, separation of deep tissues, antibiotics, drainage of pus, 
debridement of wound, isolation of bacteria, and requirement of inpatient care. Surgeons should 
assess each parameter and provide a numeric score based on the objective standard of incision 
appearance and the clinical outcome of infection. The following additional points are added: 
antibiotic treatment of SSI (10 points), drainage of pus under local anesthesia (5 points), 
debridement of wound under general anesthesia (10 points), isolation of bacteria from incision 
(10 points), and stay in hospital over 14 days (5 points). The total score, ranged from 0 to 100, 
is calculated to define the severity of incision according to the percentage of each 
characteristic’s impact on incision [18,19]. Please refer to Annex 6. 
3. 
Incidence of incisional wound separation or wound dehiscence requiring intervention; 
4. 
Incidence of delayed incisional wound healing events; 
5. 
Incidence of other adverse events; 
6. 
Product complaints. 
2) Selection of method and time to evaluate, record, and analyze the safety parameters 
The safety parameters are recorded on the e-CRF according to the Investigator’s record, 
medical record, and examination results, which are collected at each follow-up visit 2, 3, 4 and 
5. See Section 8 for the Analysis Method of Safety Parameters. 
7.2 Trial Flow Chart 
7.2.1 Flow diagram of clinical trial 
The schedule and events table of the trial is as follows: 
Project 
V1 
V2 
V3 
V4 
V5 
Withdraw 
visit 
Event/time point 
Screening 
/baseline: 
within 14 days 
prior to surgery 
Randomizat
ion: prior to 
surgery 
Surgery 
5-7 days 
after 
surgery 
28-35 days 
after surgery 
For subjects 
randomized 
but without 
any of study 
sutures used 
and 
for 
subjects 
who  
withdraw 
ICFi 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
25 
Informed consent 
X 
 
 
 
 
 
Demographic 
information 
X 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
Inclusion & Exclusion 
Criteria 
X 
X 
 
 
 
 
Fasting plasma 
glucose test a 
X 
 
 
 
 
 
Blood/urine 
pregnancy test b 
X 
 
 
 
 
 
Medical 
Record/ 
Surgical history c 
X 
X 
 
 
 
 
Physical examination 
X 
 
 
 
 
 
Concomitant 
Medications d 
X 
X 
X 
X 
X 
 
Surgical data e 
 
 
X 
 
 
 
Concomitant 
treatment 
 
 
X 
X 
X 
 
Imaging 
data 
of 
incision f 
 
 
 
X 
X 
 
Discharge date 
 
 
 
X 
 
 
Wound healing grade 
assessment g 
 
 
 
X 
 
 
Modified 
Hollander 
Wound 
Evaluation 
Scale g 
 
 
 
 
X 
 
Postoperative incision 
pain score 
 
 
 
X 
X 
 
EQ-5D-5L 
X 
 
 
X 
X 
 
SSI/ASEPSIS score 
 
 
 
X 
X 
 
Complications 
of 
incision h 
 
 
 
X 
X 
 
Adverse event 
 
X 
X 
X 
X 
X 
Product complaint 
 
 
X 
X 
X 
X 
End of study 
 
 
 
 
X 
X 
a. The result of the examination should be completed within 7 days prior to the signing of ICF. 
b. Applicable to female subjects of childbearing age (less than 2 years post-menopausal). The 
result of the examination completed within 7 days prior to the signing of ICF is acceptable. 
c. Disease newly diagnosed or existing within the period from 30 days prior to the signing of 
ICF to randomization are collected. 
d. Concomitant medications used within the period from 7 days prior to the signing of ICF to 
the end of the study will be documented, excluding medications for surgical anesthesia. 
e. The surgical data should include suturing time, length of operation, total operating room 
time, intraoperative suture performance indicators (collected data of the second case using 
 and 
 from each Investigator), and intraoperative 
use of suture devices. 
f. 
At V4, a picture of complete neck anterior view containing full length of the incision should 
be collected; at V5, 5 pictures of incision should be collected [including a picture of 
complete neck anterior view containing full length of the incision, a picture taken parallel 
to the incision plane, a picture taken at a 45° angle to the incision plane, and incision lateral 
view pictures of both sides (one for each)] for assessment done by independent Central 
Imaging evaluators. 
g. Assessed by Central Imaging evaluators using imaging data provided by study sites. 
h. Including incisional wound separation or wound dehiscence requiring intervention, target 
incisional wound healing delay, etc. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
26 
i. 
For subjects who are randomized but without any of study sutures used for incision closure, 
this visit is conducted as early as possible. For subjects who withdraw ICF, this visit is 
conducted as early as possible with subjects’ permission. Telephone visit is acceptable. 
7.2.2 Specifications for Use of Devices 
According to Instructions for Use (IFU) and technical manual of the product, the requirements 
for the use of study product are as follows: 
1) 
Indications/Scope of Application of Product 
Investigational products (
 and 
): indicated for use in 
soft tissue approximation where the use of absorbable sutures is appropriate 
Control products: 
: It is indicated for use in soft tissue approximation, including use in pediatric 
cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than 
contact with cornea and sclera). 
 suture is not indicated in adult cardiovascular tissue, 
microsurgery and neural tissue. These sutures are particularly useful where the combination of 
an absorbable suture and extended wound support (up to six weeks) is desirable. 
: It is indicated for use in general soft tissue approximation and/or ligation, 
but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. 
2) 
Recommended Methods of Operation 
 device is designed to be used in continuous suture patterns. 
 
device is intended to be used without anchoring knots to begin or terminate the device line. 
Use as required per surgical procedure. 
1. 
Secure the fixation loop portion to robust tissue by taking a bite in the designated tissue, passing 
the needle through the loop and pulling tautly around the anchoring tissue. 
2. 
After 
 Device is anchored into the tissue, grasp the strand and approximate 
tissue to the desired tension. Bites, or passes through the tissue, can be taken in a continuous suturing 
technique to approximate the wound. Care should be taken to utilize the 
 Device 
on the barbed segments only. Do not attempt to approximate wounds using the non-barbed segment 
near the needle, as the barbs are required for successful wound approximation with the 
 
 Device 
3. 
(1) To complete the closure in subcuticular closure, take at least one pass in the reverse 
direction. Then pass the needle across the incision and take a split thickness bite perpendicular to 
the incision and exit the skin. 
 
(2) To complete the closure in all other tissue layers, take at least two passes in the reverse 
direction to complete the closure. 
4. 
Then gently pull on the free end of the device and cut flush with the surface of the tissue. 
To remove the entire 
 Device: Cut the 
 Device at the end 
anchored with the loop, and then pull the distal end to remove the device. 
 device is designed to be used in continuous suture patterns. 
 
 Device is intended to be used without anchoring knots to begin or terminate 
the device line. 
Use as required per surgical procedure. 
1. 
Secure the fixation loop portion to robust tissue by taking a bite in the designated tissue, passing 
the needle through the loop and pulling tautly around the anchoring tissue. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
27 
2. 
After 
 Device is anchored into the tissue, grasp the strand and 
approximate tissue to the desired tension. Bites, or passes through the tissue, can be taken in a 
continuous suturing technique to approximate the wound. Care should be taken to utilize the 
 
 Device on the barbed segments only. Do not attempt to approximate wounds 
using the non-barbed segment near the needle, as the barbs are required for successful wound 
approximation with the 
 Device. 
3. 
(1) To complete the closure in subcuticular closure, take at least one pass in the reverse 
direction. Then pass the needle across the incision and take a split thickness bite perpendicular to 
the incision and exit the skin. 
 
(2) To complete the closure in all other tissue layers, take at least two passes in the reverse 
direction to complete the closure. 
4. 
Then gently pull on the free end of the device and cut flush with the surface of the tissue. 
To remove the entire 
 Device: Cut the 
 
Device at the end anchored with the loop, and then pull the distal end to remove the device. 
3) 
Warning and Precautions 
 
• 
Warning 
The fixation loop of the 
 Device should be deployed by users familiar with 
surgical procedures, techniques and tissues and the use of absorbable devices before employing 
the 
 Device for wound closure, as risk of wound separation may vary with the 
site of application and the suture material used. Surgeons should consider the quantity and 
quality of tissue in which the loop will be anchored. The use of this device may be inappropriate 
in highly vascularized tissue or fragile tissue that cannot withstand potential further 
tightening/constriction within the loop. 
Surgeons should consider the in vivo performance when selecting a device for use in patients. 
The use of this device may be inappropriate in elderly, malnourished or debilitated patients, or 
in patients suffering from conditions which may delay wound healing. 
As with any foreign matter, prolonged contact of any device with salt solutions, such as those 
found in the urinary or biliary tracts may result in calculus formation. As an absorbable device, 
 may act transiently as a foreign matter. Acceptable surgical practice should be 
followed for the management of contaminated or infected wounds. 
As this is an absorbable device material, the use of supplemental nonabsorbable sutures should 
be considered by the surgeon in the closure of the sites which may undergo expansion, 
stretching or distention or which may require additional support. 
The safety and efficacy of the 
 Device have not been established for use in 
fascial closures (including abdominal wall, thoracic and extremity fascial closures), 
gastrointestinal anastomoses, cardiovascular tissue, neural tissue, osseous tissue, tendinous 
tissue, ophthalmic surgery or for use in microsurgery. 
Do not re-sterilize/reuse. Reuse of this device (or portions of this device) may create a risk of 
product degradation, which may result in device failure and/or contamination, which may lead 
to infection or transmission of blood-borne pathogens to patients and users. Discard open 
packages and unused devices. Discard packaging that is damaged or opened. Do not use after 
expiration date. 
Precautions 
The 
 Device contains a loop end and barbs to anchor tissues and does not require 
knots to secure the device. Tying of knots on the barbed section of the device will damage the 

 LLC
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
28 
barbs and potentially reduce their efficacy. For the device to function properly, the 
 
 Device must first be anchored in robust tissue using the fixation loop. Then subsequently 
engage the barbs into the tissue in a standard closure pattern. When completing placement of 
the barbed segment in subcuticular tissue, take at least one additional pass in the reverse 
direction to lock the 
 Device in place. In all other tissue layers, take at least two 
passes in the reverse direction to lock the 
 Device in place. 
Avoid contacting the 
 Device with other materials (e.g., surgical gauze, drapes, 
etc.) in the surgical field to prevent ensnaring on the barbs. 
If the barbs catch, carefully pull the material in the opposite direction of the needle to disengage 
it from the barbs. 
When using the 
 Device subcutaneously, the device should be placed as deeply 
as possible in order to minimize erythema and induration normally associated with absorption. 
Care should be taken to avoid damage when handling the device. Avoid crushing or crimping 
the suture material with surgical instruments (e.g. needle holders or forceps). Do not attempt to 
remove memory in the polymer by running fingers down the suture material as this can damage 
the barbs. 
Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare 
instances wound separation are typical or foreseeable risks associated with any suture and hence 
are also potential complications associated with the 
 device. 
Acceptable surgical practice should be followed with respect to drainage and closure of infected 
wounds. To avoid damaging needle points and swage areas, grasp the needle in an area one-
third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles 
may cause them to lose strength and be less resistant to bending and breaking. Users should 
exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard 
used needles in designated biohazard “sharps” containers. 
Store at or below 30℃. 
 
Warning  
The fixation loop of the 
 Device should be deployed by users familiar 
with surgical procedures, techniques and tissues and the use of absorbable devices before 
employing the 
 Device for wound closure, as risk of wound separation 
may vary with the site of application and the suture material used. Surgeons should consider 
the quantity and quality of tissue in which the loop will be anchored. The use of this suture may 
be inappropriate in highly vascularized tissue or fragile tissue that cannot withstand potential 
further tightening/constriction within the loop. 
Surgeons should consider the in vivo performance when selecting a device for use in patients. 
The use of this device may be inappropriate in elderly, malnourished or debilitated patients, or 
in patients suffering from conditions which may delay wound healing. 
As with any foreign matter, prolonged contact of any device with salt solutions, such as those 
found in the urinary or biliary tracts may result in calculus formation. As an absorbable device, 
 Device may act transiently as a foreign matter. Acceptable surgical 
practice should be followed for the management of contaminated or infected wounds. 
As this is an absorbable device material, the use of supplemental nonabsorbable sutures should 
be considered by the surgeon in the closure of the sites which may undergo expansion, 
stretching or distention or which may require additional support. 
The safety and efficacy of the 
 Device have not been established for 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
29 
use in fascial closures (including abdominal wall, thoracic and extremity fascial closures), 
gastrointestinal anastomoses, cardiovascular tissue, neural tissue, osseous tissue, tendinous 
tissue, ophthalmic surgery or for use in microsurgery. 
Do not re-sterilize/reuse. Reuse of this device (or portions of this device) may create a risk of 
product degradation, which may result in device failure and/or contamination, which may lead 
to infection or transmission of blood-borne pathogens to patients and users. Discard open 
packages and unused devices. Discard packaging that is damaged or opened. Do not use after 
expiration date. 
Precautions 
The 
 Device contains a loop end and barbs to anchor tissues and does 
not require knots to secure the device. Tying of knots on the barbed section of the device will 
damage the barbs and potentially reduce their efficacy. For the device to function properly, the 
 Device must first be anchored in robust tissue using the fixation loop. 
Then subsequently engage the barbs into the tissue in a standard closure pattern. When 
completing placement of the barbed segment in subcuticular tissue, take at least one additional 
pass in the reverse direction to lock the 
 Device in place. In all other tissue 
layers, take at least two passes in the reverse direction to lock the 
 
Device in place. 
Avoid contacting the 
 Device with other materials (e.g., surgical gauze, 
drapes, etc.) in the surgical field to prevent ensnaring on the barbs. If the barbs catch, carefully 
pull the material in the opposite direction of the needle to disengage it from the barbs. 
Skin devices that remain in place longer than 7 days may cause localized irritation and should 
be snipped off or removed if indicated. Subcuticular devices should be placed as deeply as 
possible to minimize the erythema and induration normally associated with absorption. 
Under some circumstances, notably orthopedic procedures, immobilization of joints by external 
support may be employed at the discretion of the surgeon. Consideration should be taken in the 
use of absorbable devices in tissue with poor blood supply as device extrusion and delayed 
absorption may occur. In handling this or any other device material, care should be taken to 
avoid damage from handling. 
Avoid crushing or crimping damage due to application of surgical instruments such as forceps 
or needle holders. Do not attempt to remove memory in the polymer by running fingers down 
the suture material as this can damage the barbs. 
Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare 
instances wound separation are typical or foreseeable risks associated with any suture and hence 
are also potential complications associated with the 
 device. 
Acceptable surgical practice should be followed with respect to drainage and closure of infected 
wounds. To avoid damaging needle points and swage areas, grasp the needle in an area one-
third (1/3) to one-half (1/2) of the distance from the swaged end to the point. Reshaping needles 
may cause them to lose strength and be less resistant to bending and breaking. Users should 
exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard 
used needles in designated biohazard “sharps” containers. 
Store at or below 30℃. 
7.2.3 Study Procedures 
1) 
Visit 1 – Screening/ Baseline visit 
The following screening procedures should be completed prior to any study procedure: 
• 
The subject must be given enough time to review and sign the ICF; 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
30 
• 
Collection of demographic information (e.g. date of birth, gender, ethnic origin, etc.); 
• 
Review and collection of medical/surgical history; 
• 
Urine/blood pregnancy test: The result of the examination completed within 7 days prior 
to the signing of ICF is acceptable. If multiple examinations are completed, the result of 
the examination closest to the time of operation shall prevail; 
• 
Fasting plasma glucose test: The result of the examination completed within 7 days prior 
to the signing of ICF is acceptable. If multiple examinations are completed, the result of 
the examination closest to the time of operation shall prevail; 
• 
Review/collection of inclusion/exclusion criteria, and determining whether the subject 
meets the criteria or not; 
• 
Physical examination: Including body height, body weight, physical examination results 
of the head and neck, and other contents; 
• 
Concomitant medications: Medications started within 7 days prior to the signing of ICF 
or currently used 
• 
EQ-5D-5L。 
a. 
Screening 
Subjects will be consented prior to any study-specific screening procedures being conducted. 
Subjects will be considered enrolled into the study upon satisfaction of the following criteria: 
• 
Completion of the informed consent process; 
• 
It is determined by the investigator that the subject meets all inclusion criteria and does 
not meet any exclusion criteria (Section 7.1.5). The verification must be conducted by the 
Principal Investigator (PI) and/or authorized investigators prior to randomization. 
b. 
Screen Failures 
Subjects who signed the ICF and were screened but not successfully randomized will be 
considered screen failures. For subjects who are determined to be screen failures, only the 
following data will be collected: 
• 
Informed consent date; 
• 
Demographic information (age, race, gender, and ethnicity); 
• 
Reason for screening failure. 
2) 
Visit 2 -Randomization 
The following information must be obtained during randomization: 
• 
Confirmation of inclusion / exclusion criteria; 
• 
Update of medical/surgical history (prior to randomization); 
• 
Randomization: Central randomization prior to the surgical procedure; 
• 
Concomitant medications; 
• 
Adverse event (AE) (collected since randomization). 
Randomization will occur if the patient meets all inclusion criteria and does not meet any 
exclusion criteria. 
The central randomization system will be used in this study, so that subjects will not know their 
treatment group allocation. Each subject will be randomized to one of the three treatment groups 
according to the allocation ratio of 1:1:1, and the only difference between the investigational 
groups and control group lies in the suture material. Each group will include approximately 167 
subjects.  
3) 
Visit 3-Surgery 
The following information must be obtained during the surgical procedure: 
• 
Surgical data, including: 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
31 
• 
Use: Including the code and quantity of study product used, and tissue layer at which 
the study product is used; 
• 
Suturing time: It is defined as the time required from the first needle insertion for 
stitching ribbon muscles to the completion of intradermal suture (min); 
• 
Length of operation: It is defined as the time from the incision of skin to the closure 
of skin (min); 
• 
Total operating room time: It is defined as the time from the start of anesthesia on 
the subject to the time of leaving the operating room (min); 
• 
Intraoperative suture performance indicators (using VAS scale, see Annex 4-2, 
collected data of the second case using 
 and 
 
 from each Investigator): Ease to pass through tissues, surgical operation profile 
(including surgical handfeel), suture memory, and wear resistance of suture; 
• 
Concomitant medications: Excluded intraoperative medications for anesthesia; 
• 
Concomitant treatment; 
• 
AEs; 
• 
Product complaints. 
Surgical procedures 
a. 
Open thyroid surgical procedure via the anterior cervical curved incision (Kocher’s 
incision): 
It is recommended that, the surgery, including the incision closure procedure be performed by 
not more than three groups of surgeons in each study site, to minimize bias and variation. Open 
thyroid surgery should be performed according to the diagnosis and treatment practice or 
specific guidelines of each institution. As required by the expert consensus, the method to make 
an anterior cervical curved incision (Kocher’s incision): Make a collar-like, curved incision 
about 1-2 cm above the suprasternal notch along a pre-existing skin crease, and parallel to the 
skin crease. Pay attention to avoiding incision unparallel to local skin grease and subsequently 
formed a cross. After surgical healing, the incision should be hidden by skin crease of the neck 
and hence covert. It should be noted that, when making an anterior cervical transverse curved 
incision, the cervical incision should be made as symmetrical as possible according to the 
principles of human body aesthetics, to avoid deviation and inclination, disproportion or poor 
arc of the incision. 
The postoperative drainage tube (if any) should be placed in another incision made, other than 
the incision above, and cannot be placed in full length of the incision. 
b. 
Incision closure procedure using study products: 
All the subjects must have their incision closed sutures according to the treatment group to 
which they are assigned. The specific suture materials and methods are as follows: 
Investigational group 1: Use the study device 
) for 
continuous suture of the ribbon muscles, 
) for 
interrupted suture of the platysma, and 
) for continuous 
subcuticular suture; 
Investigational group 1 
Level 
Suture Material 
Suture Technique 
Product Code 
Ribbon 
muscles 
 
Continuous 
 
Platysma 
 
Interrupted 
 
Intradermal 
 
Continuous 
 
 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
32 
Investigational group 2: Use 
) for continuous suture of the ribbon 
muscles, 
 for interrupted suture of the platysma, 
and the study device 
) for continuous 
subcuticular suture; 
Investigational group 2 
Level 
Suture Material 
Suture Technique 
Product Code 
Ribbon 
muscles 
 
Continuous 
 
Platysma 
 
Interrupted 
 
Intradermal 
 
 
Continuous 
 
 
Control group: Use the control device 
) for continuous suture of 
the ribbon muscles, 
) for interrupted suture of the 
platysma, and the control device 
) continuous subcuticular 
suture. 
Control group 
Level 
Suture Material 
Suture Technique 
Product Code 
Ribbon 
muscles 
 
Continuous 
 
Platysma 
 
Interrupted 
 
Intradermal 
 
Continuous 
 
 
None study product should be used once incision closure, despite of any reason leading to original 
sutures removal, incisions re-opening or re-suturing. 
 
The method of use of the investigational devices is as follows: 
1. 
Secure the fixation loop portion to robust tissue by taking a bite in the designated tissue, passing 
the needle through the loop and pulling tautly around the anchoring tissue. 
2. 
After the device is anchored into the tissue, grasp the strand and approximate tissue to the 
desired tension. Bites, or passes through the tissue, can be taken in a continuous suturing technique 
to approximate the wound. Care should be taken to utilize the device on the barbed segments only. 
Do not attempt to approximate wounds using the non-barbed segment near the needle, as the barbs 
are required for successful wound approximation with the device. 
3. 
(1) To complete the closure in subcuticular closure, take at least one pass in the reverse 
direction. Then pass the needle across the incision and take a split thickness bite perpendicular to 
the incision and exit the skin. 
 
(2) To complete the closure in all other tissue layers, take at least two passes in the reverse 
direction to complete the closure 
4. 
Then gently pull on the free end of the device and cut flush with the surface of the tissue. 
To remove the entire device: Cut the device at the end anchored with the loop, and then pull the 
distal end to remove the device. 
Other sutures used in the trial should be used as per surgical procedure. Do not use skin adhesive 
at the incision site after the suture is done. 
Postoperative care: 
Postoperative care should be given according to the routine practice of the study site or the 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
33 
specific requirements of postoperative care guidelines. The subjects’ condition should be 
closely monitored until they are discharged. 
4) 
Visit 4 – Day 5-7 post-surgery 
The following information must be obtained at this visit: 
• 
Concomitant medications; 
• 
Concomitant treatment; 
• 
Imaging data of incision: 1 picture of complete neck anterior view containing full length 
of the incision; 
• 
Wound healing grade assessment: Assessed by Central Imaging evaluators according to 
the imaging data; 
• 
Postoperative incision pain score; 
• 
EQ-5D-5L; 
• 
Incision SSI, and ASEPSIS score assessed in subjects with confirmed SSI; 
• 
Wound complication assessment, including: incisional wound separation or incisional 
wound dehiscence requiring intervention, delayed incisional wound healing, etc.; 
• 
Discharge date; 
• 
AEs； 
• 
Product complaints. 
5) 
Visit 5 – Day 28-35 post-surgery 
The following information must be obtained at this visit: 
• 
Concomitant medications; 
• 
Concomitant treatment; 
• 
Imaging data of incision: Collect 5 pictures of incision (including a picture of complete 
neck anterior view containing full length of the incision, a picture taken parallel to the 
incision plane, a picture taken at a 45° angle to incision plane, and incision lateral view 
pictures of both sides (one for each); 
• 
Modified Hollander Wound Evaluation Scale; 
• 
Postoperative incision pain score; 
• 
EQ-5D-5L; 
• 
Incision SSI, and ASEPSIS score assessed in -subjects with confirmed SSI; 
• 
Wound complication assessment, including: incisional wound separation or incisional 
wound dehiscence requiring intervention, delayed incisional wound healing, etc.; 
• 
AEs; 
• 
Product complaints. 
6) 
Withdraw visit – For subjects randomized but without any of study sutures used and 
for subjects who withdraw ICF  
For subjects who are randomized but without any of study sutures used for incision 
closure, this visit is conducted as early as possible. For subjects who withdraw ICF, this 
visit is conducted as early as possible with subjects’ permission. Telephone visit is 
acceptable. The following information must be obtained at this visit: AEs; Product 
complaints. 
7.3 Monitoring Plan 
This study is performed according to the Good Clinical Practice for Medical Device Trials and 
related laws and regulations, such as ISO 14155, the Declaration of Helsinki. 
The Sponsor takes the monitoring responsibility for the clinical trial and will select the qualified 
monitor to execute the monitoring responsibility. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
34 
The monitor should comply with the related laws and regulations and the standard operating 
procedure (SOP) established by the Sponsor to monitor each study phase. 
The monitor should contact and visit the investigators at a regular basis and make the on-site 
visit/monitoring during the study. The monitor should visit each site right after the first subject 
is enrolled, and regular site visits during the duration of the study. 
The monitoring will include visits to the clinical trial institution, verification of source data, 
communication with investigators and clinical trial institution, ensuring that this study will be 
performed strictly in compliance with the protocol and the requirements of regulations and 
Good Clinical Practice, etc. 
The on-site monitoring includes verifying the source document and checking whether source 
data is true, accurate, complete and clear, the original document of each subject is complete. 
This study might be audited by the Sponsor or inspected by Regulatory Authority. If such 
audit/inspection is performed, the Investigator and the site must agree the auditor to look up the 
records of subjects. The Investigator agrees the Sponsor or its appointed representative and 
Regulatory Authority to monitor all project-related study documents on site by signing on the 
signature page of this trial protocol. 
See the Monitoring Plan for details. 
8 Statistical Considerations 
8.1 Statistical Design, Method and Analysis Procedure 
This study is a multicenter, prospective, randomized controlled study to evaluate the of 
 
 and 
 used in thyroid surgery to suture surgical incision. Prior 
to surgery subjects will be randomized to the investigational group 1 
), 
investigational group 2 (
) or the control group according to the 
allocation ratio of 1:1:1. The primary efficacy endpoint is the proportion of subjects achieving 
Grade A wound healing (success) of surgical incision in each group. A blind assessment will be 
performed on the wound healing status by independent Central Imaging evaluators on Day 5-7 
post-surgery using the imaging data (a picture of complete neck anterior view, covering full 
length of the incision). 
This is a non-inferiority trial with two treatment group comparisons, investigational group 1 
versus control group, and investigational group 2 versus control group. The overall family-wise 
error rate is controlled at 0.025 level using the Holm’s multiple comparisons procedure. The 
expected success rate is 98% for all the three groups. 
For each of the two comparisons, the statistical hypotheses for testing the non-inferiority of the 
investigational group to control is presented as follows: 
• 
H0: PT - PC ≤ -0.05 tested against the alternative hypothesis 
• 
Ha: PT - PC> -0.05 
PC is the proportion of successes (Grade A healing) in the control group and PT is the proportion 
of successes in each of the investigational groups (1 and 2). 
The proportion of subjects with Grade A healing will be summarized for each treatment group 
and will be calculated as the number of subjects with Grade A healing divided by the total 
number of subjects randomized to that treatment who had the surgical wound closed using the 
randomized suture. Within-treatment group, two-sided 95% confidence intervals for the 
proportions of successes will be provided using the Clopper-Pearson method.  
For the primary endpoint analysis, the Holm’s step-down procedure will be used. For each of 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
35 
the two group comparisons, the p-value associated with the non-inferiority test will be 
calculated using the Normal approximation Z (pooled) statistic. If the smaller p-value is smaller 
than 0.0125, then the null hypothesis associated with this p-value will be rejected and it will be 
concluded that the associated Test product is non-inferior to Control; subsequently, the larger 
p-value will be compared to 0.025 in order to test the non-inferiority of the other Test product 
to Control. If the smaller p-value is larger than 0.0125, then neither of the null hypotheses can 
be rejected and it will be concluded that, for both investigational devices, the study failed to 
demonstrate non-inferiority to Control.     
The primary endpoint will be analyzed using the Full Analysis Set (FAS) and Per-Protocol (PP) 
sets. The PP analysis will be considered the primary analysis, while the FAS analysis will be 
considered supportive. The analysis sets for this study are defined in section 8.8. 
The following secondary efficacy endpoints will be summarized descriptively by treatment group 
for the FAS: 
1. 
Incision suturing time, defined as the time required from the first needle insertion for 
stitching ribbon muscles to the completion of intradermal suture (min); 
2. 
Modified Hollander Wound Evaluation Scale; 
3. 
Postoperative incision pain score (VAS Scale); 
4. 
Health related quality of life scale (EQ-5D-5L). 
In addition, the following safety endpoints will be summarized descriptively t by treatment 
group for the Safety analysis set:  
1. 
Incidence of postoperative SSI; 
2. 
ASEPSIS score (only assessed in subjects with confirmed SSI); 
3. 
Incidence of incisional wound separation or wound dehiscence requiring intervention; 
4. 
Incidence of delayed incisional wound healing events; 
5. 
Incidence of other AEs; 
6. 
Product complaints. 
The incidence of AEs will be assessed according to the classification of event and summarized 
descriptively by treatment groups. Incidence of AEs will also be assessed by onset time 
(intraoperative or postoperative), relationship to study surgical procedure, relationship to the 
study product, severity, and seriousness. 
All continuous variables will be summarized by number of subjects, mean, standard deviation, 
median, minimum and maximum. All categorical data will be summarized by frequencies and 
associated percentages. No inferential statistics will be generated for secondary efficacy and 
safety endpoints. 
8.2 Calculation of Sample Size 
8.2.1 Total Sample size 
This clinical study will enroll approximately 501 subjects, 167 for each treatment group. 
One hundred fifty (150) evaluable subjects per study arm will achieve 80% power to detect a 
non-inferiority margin difference in group proportions of -0.05 for each of the two comparisons 
using a Pearson Chi-square test with a one-sided significance level of 0.0125. The proportion 
of successes in the Control group is assumed to be 0.98. The proportion of successes in Test 
group (
 or 
) is assumed to be 0.93 under the null hypothesis 
of inferiority. The power was computed for the case when the actual proportion of successes in 
the Test group is 0.98.  
In order to account for a potential 10% dropout rate, approximately 167 subjects per arm will 
be enrolled, for a total of approximately 501 subjects. 
8.2.2 Number of Subjects for Clinical Trial of Each Disease Entity and Reasons for 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
36 
Determination 
A total of approximately 501 Chinese subjects who undergo thyroid surgery will be included in 
the study. With consideration to the angle of incision, subjects with stage IV thyroid cancer and 
anaplastic thyroid cancer are excluded, but there are no restrictions on other disease. 
8.2.3 Minimum and Maximum Number of Subjects in Each Clinical Trial Institution and 
Reasons for Determination 
In China, total of approximately 501 subjects undergoing thyroid surgery in approximately 10 
study sites will be enrolled into the study. Each site should enroll more than 125 subjects (25% 
of the total number). 
During the implementation of the study, the Sponsor will try to ensure the consistency of 
number of subjects among sites in order to reduce the variation of the primary endpoint (and 
subject safety indicators) among sites.  
8.3 Significance Level and Power of Clinical Trial 
Determination of the sample size was performed assuming 80% power and a significance level 
of 0.0125 for each comparison. To control the overall Type I error rate at a 0.025 level for the 
two hypotheses being tested, Holm’s stepdown multiple comparison procedure is being 
utilized.8.4 Expected Dropout Rate 
The expected dropout rate in this study is 10%. 
8.5 Criterion of Acceptability/Unacceptability of Clinical Trial Result 
For the primary endpoint analysis, the Holm’s step-down procedure will be used. For each of 
the two group comparisons, the p-value associated with the non-inferiority test will be 
calculated. If the smaller p-value is smaller than 0.0125, then the null hypothesis associated 
with this p-value will be rejected and it will be concluded that the associated Test product is 
non-inferior to Control; subsequently, the larger p-value will be compared to 0.025 in order to 
test the non-inferiority of the other Test product to Control. If the smaller p-value is larger than 
0.0125, then neither of the null hypotheses can be rejected and it will be concluded that, for 
both test devices, the study failed to demonstrate non-inferiority to Control. 
8.6 Criteria and Reason for Terminating the Trial Based on the Statistical Results 
No interim analysis and corresponding early termination criteria, are planned for this trial; 
therefore this section does not apply. All the statistical analyses will be done after all the data 
are collected, and after study database lock. A Statistical Analysis Plan will be finalized prior 
to database lock and the performing of any final analyses. 
8.7 Statistical Method of All Data, together with the Handling Method of Missing, Unused 
and Error Data (including Termination and Withdrawal Halfway) and Unreasonable 
Data 
All study endpoints will be analyzed using the available data. There will be no missing data 
imputation in this study. 
8.8 Selection Criteria and Reason of Subjects Included in the Analysis 
All subjects that meet the inclusion/exclusion criteria are considered to meet the requirements 
for recruitment. 
Three analysis sets in the study are defined for this study, as follows: 
o 
FAS consists of all the enrolled subjects who were randomized and for whom the 
randomized suture materials were used for incision closure. 
o 
PP (evaluable) Set contains all the subjects in the FAS who have no major protocol 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
37 
deviation, have data available for primary efficacy endpoint and do not meet any of the 
following criteria: 
o 
Subject undergoes any of the following procedures, in addition to thyroidectomy： 
1、 Any surgical procedure which require additional neck incisions or extend the 
original incision; 
2、 Cervical lymph node dissection (except the dissection of lymph nodes in the 
VI area); 
3、Other unplanned surgical procedures (except the procedure that the investigator 
doesn’t think it will affect the original incision’s healing) 
o 
Subject’s intraoperative frozen pathology or postoperative paraffin section 
pathology suggests anaplastic thyroid cancer; 
o 
Subject receives any surgical procedures that lead to re-opening of the cervical 
incision during the period from the wound closure to the completion of study, 
except for surgeries related to surgical incision complication or study device.  
o 
Safety Set contains all the enrolled subjects who receive surgery. 
Major protocol deviations are deviations that have an impact on the primary endpoint 
assessment or randomization. These will be determined prior to database lock. 
The analysis of primary efficacy endpoint will be performed using FAS and PP Sets. However, 
while the primary analysis is based on the PP Set, FAS analysis will only be used as 
supplemental analysis. 
The secondary efficacy endpoints will be analyzed using the FAS, while the safety endpoints 
will be analyzed using the Safety Set. 
8.9 Special Information Excluded during Hypothesis Testing and Justification (If 
Applicable) 
Not applicable. 
 
9. Data Management 
Data management will be done by the Sponsor or the delegated Contract Research Organization 
(CRO) according to the SOP of data management. The data management process includes the 
establishment of capture/management system, design of CRF and database, data receiving and 
entry, data check and query, medical coding, external data management, Blind Review, 
Database Lock, data export and transmission, filing of data and data management documents, 
etc. 
The data management plan should specify the database locking process, person in charge and 
SOP document executed. Unlocking and re-locking after database lock should be pre-defined 
with the conditions and processes specified. The data management plan should specify trial data 
to be archived, management file, media, and way and time limit of archiving. 
10. Feasibility Analysis 
10.1 Feasibility analysis of success 
As stated above, the devices in the control group are surgical sutures that have been extensively 
applied in clinical practice, while the investigational products are suture devices that have brand 
new designs and have only been marketed in the US for one year; however, their main design 
elements, cutting knotless [1-5] and antimicrobial (triclosan)-coating [11,12] are mature and 
validated techniques. In the meantime, thyroid surgery incision is a clean incision, for which 
intradermic continuous suture is already a standard closure pattern. Therefore, it is likely to 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
38 
achieve the noninferiority goal in the protocol and appropriate to expect success rates of 98% 
in all treatment groups. 
 
In addition, according to the inclusion/exclusion criteria in the protocol, a large number of 
subjects can be included while the devices used in the study are supplied free of charge and 
hence will not increase the subjects’ burden, making it less difficult to enroll and screen subjects. 
To sum up, the likelihood of success in this study is relatively high. 
10.2 Feasibility analysis of failure 
As stated above, the investigational products are the combination of two mature techniques, but they 
have only been marketed in the US for one year and have not been reported in any related clinical 
literature yet. There may be some undiscovered problems that can cause some unforeseen problems 
in this study. 
In addition, in this study, subjects are required to go back to hospital for follow-up visits 1-2 
times at most after their surgery and discharged, which may make some subjects lost to follow-
up. This may not be completely avoided under the condition that subjects are fully informed. 
According to the requirements of this study, lost-to-follow up and withdrawn subjects should 
be controlled within 10% of all the subjects. 
To sum up, although the study may fail for some reasons, the overall likelihood is relatively 
small. 
 
11. Quality Control of Clinical Trials 
During the clinical study, the Sponsor and Investigator should execute their respective 
responsibilities according to the Good Clinical Practice for Medical Device Trials and 
applicable related Chinese and international regulations. They should also strictly follow the 
clinical trial protocol to ensure the quality of clinical trial. 
The Sponsor will ensure proper training on the clinical trial protocol and the use and 
maintenance of investigational medical device for all investigators participating in the trial, to 
ensure the consistency in the implementation of clinical trial protocol, the use of investigational 
medical device. 
During the implementation of study, the Sponsor is responsible for monitoring each phase of 
the clinical trial. The clinical monitor employed by the Sponsor or appointed representative 
should comply with the related standard operating procedure (SOP) and clinical trial protocol 
that are established by the Sponsor to monitor the clinical trial, to ensure the complete, accurate, 
true and reliable data. 
To ensure the quality of study, the Sponsor may authorize the eligible auditor to audit the 
clinical trial, as needed. The Investigator should allow the auditors to review the original data 
and documents related to this study after receiving the notification. 
When the Food and Drug Administration, Health Planning Department or other regulatory 
agencies send the inspection personnel to carry out the inspection, the clinical trial institution 
and Investigator should cooperate and immediately notify the Sponsor. 
 
12. Clinical Trial-Involved Ethical Issues and Informed Consent 
12.1 Ethical Concerns 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
39 
Ethical issues involved in this study have been stipulated according to China’s laws and 
regulations and international consensus such as the Declaration of Helsinki, the protocol design 
has taken ethical principles into full consideration, and the rights, safety and health of trial 
subjects are the most important concerns. The specific contents should at least include: 
1) Regulations to make sure subjects are fully informed 
2) Regulations that respect and protect subjects’ privacy, and that keep records possibly identifying 
subjects confidential 
3) The production of investigational product should meet the relevant requirements of applicable 
quality management system for medical devices; the processing and storage of investigational 
product should meet the requirements of IFU and SOP. The investigational product should be used 
according to the approved protocol and related operation instructions. The reference product should 
be used to ensure the safety of subjects to the maximum extent. 
4) Qualified clinical study sites and investigators should be selected, and investigators should make 
medical decisions that are in the best interest of subjects 
5) In the inclusion/exclusion criteria of the study, inclusion criteria for subjects of different groups 
should be identical; subjects who withdraw from the study will not affect the treatment of disease; 
Subjects who suffer from study-related injury will be given appropriate treatment and compensation 
(see ICF) 
6) Before any subject is recruited, the study protocol and its amendments, ICF and other study-
related documents applicable must be submitted to the corresponding EC for review and must obtain 
written comments from the EC. 
12.2 Approval of Trial Protocol 
The trial protocol should be internally approved and filed according to the company’s SOP prior 
to submitting to the external agency (including but not limited to the government regulatory 
agencies, Ethics Committee). 
The clinical trial protocol should not be implemented until the written approval is obtained from 
the Ethics Committee according to the relevant requirements of laws and regulations. 
12.3 Process of Informed Consent and Text of Informed Consent Form 
12.3.1 Process of informed consent 
The informed consent of all subjects participating in the study must be obtained prior to 
performing any study tests/procedures. The Investigator must explain the background of the 
study presented and the benefits and risks of surgery and study to the subjects before the subject 
participates in the study. Only the subject who signs the latest informed consent form that is 
approved by the EC prior to participating in the study is eligible to participate in this study.  
Subject who has not signed the written ICF is not eligible to participate in this study. 
Each subject (or legally authorized representative) must sign and date the latest informed 
consent form that is approved by the EC prior to implementing any study-related items or 
operations not belonging to the standard treatment and after the nature of this study is fully 
clarified. 
The process of obtaining the written informed consent needs to prove that the subjects volunteer 
to participate in this study. All aspects of this study must be clarified to the subjects prior to 
signing the informed consent form, and questions raised by the subject must be clearly answered. 
The Investigator and/or designee must clearly document the process of obtaining informed 
consent in the subject clinical record. The investigator has responsibilities to ensure the process 
of obtaining the informed consent is implemented according to the Good Clinical Practice for 
Medical Device Trials and related regulations, such as ISO 14155, the Declaration of Helsinki. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
40 
12.3.2 Text of Informed Consent Form 
See ICF. 
 
13. Device Management 
In this study, the Sponsor will prove all the study products and control products. The packages 
of the products should be clearly specified with “For Clinical Trial Only”. 
13.1 Accountability of investigational devices 
All the study involved devices received must be counted, of which the quantity should be 
checked continuously throughout the study: the investigator and/trained designated person 
should record the receipt, use, dispensing and return of devices during the study properly. These 
investigational devices must be kept in a secure location with restricted access and stored 
according to the conditions outlined in the IFU. In all circumstances, the investigational device 
is intended for use by the investigator or sub-investigator for subjects consented for 
participation in this clinical study only. 
An accountability log will be used by each site to acknowledge receipt of all investigational 
devices and to record the disposition of all investigational devices on an ongoing basis 
throughout the course of the study. The process of device accountability and checking should 
be thoroughly explained during the study site initiation period. The responsible monitor will 
review the investigational device accountability at each monitoring visit. 
In addition, the following but not limited paper study documents must be maintained as well: 
• 
Each subject’s product accountability tables of implanted device (this may include the 
original document and/or packaging label of the investigational/control product used); 
• 
All forms documenting the investigational devices return process; 
• 
All forms related to transport and receipt of investigational devices. 
13.2 Return of investigational devices 
All unopened and unused (e.g., expired), opened and unused, damaged, mislabeled or 
malfunctioning investigational devices must be returned to the Sponsor with related form. 
During the study site initiation visit, the Sponsor should train the investigator thoroughly. 
 
14. Regulations of Adverse Event and Device Complaint Reporting 
14.1 Adverse Event 
AE is an untoward medical occurrence during the clinical study and which does not necessarily 
have a causal relationship with the study medical device. 
Ever since the randomization of subjects, the investigator must confirm if any AE occurs, and 
if any, determine the relationship between AE and investigational device or surgical procedure, 
when evaluating subjects enrolled by clinical study each time. 
Postoperative fever, postoperative pain, incisional scar formation and laboratory abnormalities 
are expected to occur after surgery and will not be recorded as AE in this study, unless the 
investigator believes the degree of pain or fever exceeds the subject’s normal expected range 
after surgery or related to study devices. 
Other AEs, investigational device failure and other product problems must record in the medical 
record and entered the e-CRF. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
41 
The severity of AE will be separated into the following grades: 
Mild: Awareness of sign or symptom that does not interfere with the subject’s usual activity or 
is transient, resolved without treatment and with no sequelae, 
Moderate: Interferes, but does not hinder, the subject’s usual activity and may require treatment; 
Severe: Causes severe discomforts, results in major impact on the subject’s activities of daily 
living and requires treatment or intervention. 
The causal relationship should be assessed as follows: 
Unrelated 
There is no correlation between the AE and the use of medical device 
Possibly 
unrelated 
The occurrence of AE is more likely to be associated with other factors, e.g.: 
concomitant medication or concomitant disease, or the occurrence time of the 
event does not suggest a causal relationship with the use of study-related device. 
Possible: 
The occurrence of AE may be caused by study-related device. Other factors may 
have contributed to the event, e.g.: concomitant medication or concomitant 
disease. The event occurs within a reasonable time after the use of study-related 
device and the causal relationship between the event and the use of study-related 
device cannot be ruled out. 
Probable 
The occurrence of AE is probably caused by the use of study-related device. The 
event occurs within a reasonable time after the use of study-related device, e.g.: it 
is confirmed after the medical device is taken out. It is unlikely to have another 
explanation for the event (e.g. concomitant medication or concomitant disease). 
Definitely 
Related: 
The occurrence of AE has been confirmed as a definite side effect of the medical 
device and cannot be explained by other reasons (e.g. concomitant medication and 
concomitant disease). The occurrence time of the event highly suggest a causal 
relationship (e.g. reaction after removal of medical device and replantation of 
medical device). 
 
14.2 Serious Adverse Event 
SAE refers to any untoward medical occurrence in a clinical trial that results in death or serious 
deterioration of health status, including life-threatening conditions or damage, permanent defect 
of body structure or body function, events requiring inpatient hospitalization or prolongation of 
existing hospitalization, those requiring medical or surgical intervention to avoid permanent 
defect of body structure or body function; and those resulting in fetal distress, fetal death or 
congenital anomaly/birth defect, etc. 
A planned hospitalization and/or medical intervention for pre-existing conditions, or a 
procedure required by the protocol, without serious deterioration in health, is not considered to 
be a serious adverse event. 
14.3 Device Complaints 
A product complaint is defined as any written, electronic or oral communication that alleges 
deficiencies related to the identity, labelling, quality, durability, reliability, safety, efficacy, or 
performance of a device after it is released for distribution. In the event of any device complaint, 
the study site must inform the monitor and track and report it according to the process stipulated 
by the Sponsor. The study site must inform the study monitor of all device complaints of the 
study groups and control group. The monitor will track and report device complaints according 
to the method and time limit stipulated by the Sponsor and China’s laws and regulations and 
return related products to the quality department of J
 
upon the request of the Sponsor. 
14.4 Device Defects 
Device defects refer to unreasonable risks of medical device existing during the clinical trial 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
42 
under normal use, which may endanger human health and life safety, such as labeling error, 
quality problem, malfunctioning, etc. 
In the event of any device defect that may lead to SAE, the Sponsor should report it to the Food 
and Drug Administration Department and Health Planning Department at the same level within 
5 working days after the awareness of the defect. The Sponsor will notify other clinical trial 
institutions and investigators participating in the trial and notify the EC of the clinical trial 
institution involved in a timely manner via its medical device clinical trial management 
department. The investigator should record all AEs occurring and device deficiencies found in 
the process of clinical trial, work with the Sponsor to analyze the causes of the events, generate 
the written analysis report, present the comments on the continuation, discontinuation or 
termination of the trial, and report to the Ethics Committee by the administrative department 
for clinical trial of medical device of clinical trial institution for review. 
14.5 Reporting Procedure and Contact Person Information 
The investigator should ensure sufficient treatment is given for any AE experienced by a subject, 
including clinically significant laboratory test values related to this study. 
Once a subject is randomized, his/her AE should be followed up, until they are resolved or 
stabilized and the clinical outcome has been determined, or until his/her last follow-up visit (the 
earliest one shall prevail). If the investigator considers the AE is related to the study product, 
the subject must be followed up until the event is resolved and stabilized.  
The investigator must report the AE to the Sponsor via e-CRF within 2 weeks after its awareness. 
The Investigator should record the nature, severity, treatment and outcome of AE and determine 
whether the AE is related to the study device, medication, or surgical procedure defined in the 
study protocol or not. 
All the SAEs must be followed up until they are resolved (with or without sequela). When the 
event is not resolved or stable at the end of study, the medical monitor in this clinical study will 
decide whether it is necessary to collect the further follow-up information. The Investigator 
should send a report to regulatory agencies at different levels, EC and the Sponsor within 24 
hours after the awareness of a SAE. 
The Investigator must report any SAEs and any device defects possibly leading to SAE that 
occur during the study to the Sponsor and related regulatory department required by laws and 
regulation within 24 hours after the awareness of the event or defect; and provide further 
information upon the sponsor’s request. 
For any SAE and device defect that may lead to SAE, the Investigator should report it to the 
regulatory authorities, EC and the Sponsor within the time limit defined by the Sponsor. 
According to the requirements of No.25 Decree, the Sponsor should report the SAE or defect 
to the Food and Drug Administration Department and Competent Department of Health and 
Family Planning at the same level within 5 working days after its awareness. – The Sponsor 
will notify other clinical trial institutions and investigators participating in the trial and notify 
the EC of the clinical trial institution involved in a timely manner via its medical device clinical 
trial management department. 
The investigator should record all AEs occurring and device deficiencies found in the process 
of clinical trial, work with the Sponsor to analyze the causes of the events, generate the written 
analysis report, present the comments on the continuation, discontinuation or termination of the 
trial, and report to the Ethics Committee by the administrative department for clinical trial of 
medical device of clinical trial institution for review. Once a device complaint is found, the site 
should inform the Sponsor as soon as possible, and report the device related information on the 
relevant CRF. 
In the event of a device failure, the study site must notify the clinical monitor as soon as possible. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
43 
The monitor should coordinate related departments and return the product to the quality 
department of 
 according to the Sponsor’s schedule. 
The contact persons for AE and device defect reporting are as follows: 
AE: 
.com
.com 
Device Complaints: 
.com 
15. Deviation From Clinical Trial Protocol And Regulations For Clinical Trial 
Protocol Amendment 
The study protocol deviations are defined as the circumstances that fail to comply with the 
requirements of clinical trial protocol intentionally or unintentionally. 
All protocol deviations should be reported as protocol deviations to the Sponsor via protocol 
deviation form and monitoring visit report. The reporting should include the date and reason 
for protocol deviations. The Investigator should also report the protocol deviations to hospital’s 
medical device clinical trial management department, and report to EC via them, in accordance 
with the procedures and regulations and the requirements of the hospital. 
If a protocol amendment occurs, the Sponsor or designated person should submit a summary of 
changes of the study protocol to the Investigator, regulatory authority, and the Ethics Committee, 
etc. according to the relevant laws and regulations. All major amendments must be approved 
by the Ethics Committee and regulatory authority (if needed) prior to implementing any 
changes to study procedures. 
An amendment is regarded substantial when they are likely to have a significant impact on: 
• 
The safety or physical or mental integrity of the subjects; 
• 
Scientific value of trial; 
• 
Conduct or management of the trial; 
• 
Quality or safety of investigational medical device specified in the trial. 
 
16. Direct Access to Source Data and Document 
The source data is defined as all information in the subject’s original medical record and its 
approved copy regarding the clinical findings, observations and other activities in the clinical 
trial, which can be used for reproduction and evaluation of clinical trial. The source documents 
are documents on which the source data is recorded, including printed, paper or electronic 
documents. 
The subject’s medical record and other study related documents (source documents) must be 
maintained and retained by the Investigator. The Investigator should allow the monitors and 
auditors/inspectors to review all relevant subject records, including but not limited to the 
following information: 
• 
Medical/physical condition of the study subject that meets the inclusion criteria prior to 
participating this study; 
• 
Medical record documenting the informed consent process; 
• 
Operational description of use and implantation of the study product; 
• 
All inspection results and follow-up; 
• 
Examined printed output file or report (for example, X-ray film) that is dated and signed; 
• 
Imaging or video data of wound healing status; 
• 
Description of AE and follow-up of AE (description of event, severity, date of occurrence, 
duration, correlation with the study device, study procedure, outcome, and treatment of the AE, 
concomitant medications when the AE occurs); 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
44 
• 
Description of product complaint; 
• 
Study subject’s status at the end of the study or withdrawn from the study. 
Subject’s medical documents including the medical record, examination reports, films, imaging 
records, etc. The Sponsor expects that, appropriate study coordinator and/or investigator, 
appropriate original source documents and an appropriate environment will be available during 
the monitoring visit for review of study-related documents. All the inconsistencies between the 
e-CRF and source documents must be marked and resolved via discussion with the investigator 
or designated person. 
17. Finances and Insurance 
See relevant study contract and insurance document. 
 
18. Contents Should Be Covered by Clinical Study Report 
According to regulatory requirements, the clinical study report will contain the following 
contents: 
The clinical trial report should be consistent with the clinical trial protocol, mainly containing: 
(1) General information; 
(2) Synopsis; 
(3) Introduction; 
(4) Objective of clinical trial; 
(5) Method of clinical trial; 
(6) Contents of clinical trial; 
(7) General clinical information; 
(8) Investigational medical devices and control medical devices or control diagnosis and treatment 
method; 
(9) Statistical analysis method(s) and evaluation method(s) adopted; 
(10) Clinical evaluation criteria; 
(11) Organizational structure of clinical trial; 
(12) Description of ethics profile; 
(13) Clinical trial results; 
(14) Adverse events found during the clinical trial and corresponding treatment; 
(15) Analysis and discussion of clinical trial results, especially indications, scope of application, 
contraindications and precautions; 
(16) Clinical trial conclusion; 
(17) Existing problems and suggestions for improvement; 
(18) List of study personnel; 
(19) Other situations requiring explanation; 
(20) Clinical trial summary of each study site. 
19. Confidentiality Principle 
The personal data of the subject participating in the trial is confidential; however, the EC, 
CFDA, Competent Department of Health and Family Planning, or the Sponsor and its 
authorized representative may review the personal data of the subject participating in the trial 
for the purpose of their work according to the local established procedure. 
Subject confidentiality will be maintained throughout the clinical study in a way that ensures 
the information can always be tracked back to the source data. For this purpose, a unique subject 
identification code (site number and subject number) will be used that allows identification of 
all data reported for each subject. As long as the data is kept strictly confidential and that the 
privacy of the subject is ensured to be protected, the data related to this study may be available 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
45 
to third parties (for example, under the audit of regulatory authority). 
 
20. Agreement on the Publication of Trial Results 
At the conclusion of the study, a multicenter manuscript will be prepared for publication in a 
reputable scientific journal. The publication of the principal results from any single-site 
experience within the study is not allowed until the preparation and publication of the multi-
center results. Exceptions to this rule require the prior approval of the Sponsor. The analysis of 
other pre-specified and non-pre-specified endpoints will be performed by Data Management. 
Such secondary analyses, as well as other proposed investigations, will require the approval of 
the Sponsor. For purposes of timely abstract presentation and publication, secondary 
publications will be delegated to the appropriate principal authors, and final analyses and 
manuscript review for all multi-center data will require the approval of the Sponsor. 
 
21. Responsibilities That Each Party Should Bear 
21.1 Sponsor Responsibility 
1) 
The Sponsor is responsible for the initiation, application, organization and monitoring of 
clinical trial. 
2) 
The Sponsor is responsible for the organization to establish and modify the investigator 
brochure, clinical trial protocol, informed consent form, Case Report Form, relevant standard 
operating procedure and other relevant documents, carry out the training required for the 
clinical trial, and provide these documents to the investigators before the study starts. 
3) 
The Sponsor should select the qualified trial institution and investigators. 
4) 
The Sponsor should sign a written agreement with the clinical trial institution and the 
Investigator regarding the clinical trial. 
5) 
The Sponsor should provide qualified study product according to the regulatory requirements. 
The Sponsor should be responsible for the safety of investigational medical product in the 
clinical trial. The AE, SAE, and the product complaint that may cause an SAE should be 
collected and reported in accordance with the provisions. 
6) 
The Sponsor should inform the regulatory authority at every level when the Sponsor decides 
to suspend or terminate the clinical trial or at the end of the study. 
7) 
The Sponsor should ensure the Investigator conducts the study strictly in compliance with the 
clinical trial protocol, corrects the protocol deviations in a timely way, and reserves the rights 
to report, to the regulatory authority, any of issues related to this. 
8) 
The Sponsor should bear the treatment cost and relevant economic compensation for the 
clinical trial-related injury or death of subjects, with the exception of damages due to the fault 
of medical institution and medical staff in the diagnosis and treatment. 
9) 
The Sponsor should select qualified monitors for monitoring and organizing any inspections, 
as appropriate. 
21.2 Responsibilities of Clinical Trial Institution and Investigator 
1) The clinical trial institution should evaluate the relevant resources according to the features of 
investigational medical product prior to the clinical trial, so as to decide whether to participate in 
this clinical trial. 
2) The clinical trial institution should properly keep the records and essential documents of clinical 
trial according to the agreement with the Sponsor. 
3) Ensure the Investigators who are responsible for the clinical trial have the qualification in 
accordance with the requirements of related laws and regulations. 
4) The administrative department for clinical trial of medical product of clinical trial institution 
should cooperate with the Sponsor to apply to the Ethics Committee and submit the relevant 
documents prior to the clinical trial according to requirements. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
46 
5) The investigator should ensure that the relevant workers participating in the trial have the enough 
resources and proper training, and keep the training related documents. 
6) The Investigator should ensure to use the investigational medical product only for the subjects of 
this clinical trial, and may not charge any fee. 
7) The Investigator should strictly follow the clinical trial protocol, with the exception of emergency 
circumstances when the subject faces the direct risk and needs immediate clinical measures, which 
can be reported later in a written form. 
8) The Investigator is responsible for recruiting the subjects, communicating with the subject or its 
legal representative before signing the informed consent. 
9) The Investigator should protect the rights, safety and health of the subjects. 
10) In case of a SAE occurring in the clinical trial, the Investigator should protect the safety of the 
subjects and timely report the event to the regulatory authority. 
11) The investigator should record all AEs occurring and device deficiencies found in the process 
of clinical trial, work with the Sponsor to analyze the causes of the events, generate the written 
analysis report, present the comments on the continuation, discontinuation or termination of the trial, 
and report to the Ethics Committee by the administrative department for clinical trial of medical 
device of clinical trial institution for review. 
12) The Investigator should ensure that the clinical trial data is accurately, completely, clearly and 
timely recorded in the Case Report Form. 
13) The clinical trial institution and investigator should make sure that the data, documents and 
records generated in the clinical trial are timely, true, accurate, clear, and attributable. 
14) The clinical trial institution and Investigator should accept and cooperate with the monitoring 
and audit of the Sponsor, the supervision of the Ethics Committee, and the inspection of the Food 
and Drug Administration, competent department of health and family planning, etc., and provide all 
required records related to the trial. 
15) If the clinical trial needs to be suspended or terminated, the subjects should be informed 
accordingly, and it should be ensured that the subjects receive the proper care and follow-up. The 
clinical trial institution and Investigator should also report this in accordance with the regulations 
and provide a detailed written explanation. The relevant report should be submitted to the local Food 
and Drug Administration at the provincial, autonomous regional and municipal level, if necessary. 
16) The clinical trial institution and investigator reserve the rights to report to the regulatory 
authority at every level when the Sponsor violates relevant laws and regulations. 
17) The Investigator should complete all records and reports at the end of clinical trial. The 
Investigator should also ensure that the received investigational medical products are properly 
handled and recorded according to the requirements. 
21.3 Responsibilities of other interested parties 
See the study related contract. 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
47 
Statement of Investigator 
 
I agree to:  
1. Conduct this clinical trial in strict accordance with the requirements of the 
Declaration of Helsinki, China's current laws and regulations and trial protocol. 
2. Record all required data correctly in the study EDC database and input, review, and 
approve the clinical trial report on schedule. 
3. Use the investigational medical device only for this clinical trial, accurately and 
completely record the investigational medical device receipt and use condition 
during the clinical trial, and keep these records. 
4. Allow the monitor and inspectors authorized and dispatched by the Sponsor and 
regulatory authority to monitor, inspect and audit this clinical trial. 
5. Strictly implement the terms in the clinical trial contract/protocol signed by all parties. 
I have read thoroughly the clinical trial protocol, including the above statements, and I 
agree to all the above contents. 
Comments of Sponsor 
Signature (Stamp) 
                Year   Month   Day 
 
Comments of Investigator 
               Signature 
                   Year    Month   Day 
 
Comments of clinical trial institution of medical device 
Signature (Stamp) 
                Year   Month   Day             
                 
 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
48 
Annex 1: References 
 
1. 
Gililland JM, Anderson LA, Barney JK, Ross HL, Pelt C.E, Peters Cl. Barbed Versus 
Standard Sutures for Closure in Total Knee Arthroplasty: A Multicenter Prospective 
Randomized Trial The Journal of Arthroplasty 29 Suppl. 2 (2014) 135–138.  
2. 
Borzio RW, Piveci R, Kapadian BH, Jauregui JJ. Maheshwari AV. Barbed sutures in total 
hip and knee arthroplasty: what is the evidence? A meta-analysis. International 
Orthopaedics (SICOT) (2016) 40: 225–231. 
3. 
Ting NT, Moric MM, Della Valle CJ, Levine BR. Use of Knotless Suture for Closure of 
Total Hip and Knee Arthroplasties A Prospective, Randomized Clinical Trial. J or 
Arthoplasty. 2012; 27 (10): 1783-88.  
4. 
Smith EL. DiSegna ST, Shukla PY, Matzkin EG.Barbed Versus Traditional Sutures: 
Closure Time, Cost, and Wound Related Outcome in Total Joint Arthroplasty. The Journal 
of Arthroplasty. 2014; 29: 283–287. 
5. 
Gililland JM, Anderson LA, Sun G, Ericksoo JA, Peters CL. Perioperative Closure-related 
Complication Rates and Cost Analysis of Barbed Suture for Closure in TKA. Clin Orthop 
Relat Res. 2012; 470: 125–129. 
6. 
Namba RS, Inacio MC, Paxton EW. Risk factors associated with deep surgical site 
infections after primary total knee arthroplasty: an analysis of 56,216 knees. J Bone Joint 
Surg Am. 2013 May 1;95(9):775-82. 
7. 
Heath RJ, Rock CO. A triclosan-resistant bacterial enzyme. Nature. 2000 Jul 
13;406(6792):145-6. 
8. 
Ming X, Rothenburger S, Yang D. In vitro antibacterial efficacy of MONOCRYL plus 
antibacterial suture (Poliglecaprone 25 with triclosan). Surg Infect (Larchmt). 2007 
Apr;8(2):201-8. 
9. 
Ming X, Nichols M, Rothenburger S. In vivo antibacterial efficacy of MONOCRYL plus 
antibacterial suture (Poliglecaprone 25 with triclosan). Surg Infect (Larchmt). 2007 
Apr;8(2):209-14. 
10. 
Ming X, Rothenburger S, Nichols MM. In vivo and in vitro antibacterial efficacy of PDS 
plus (polidioxanone with triclosan) suture. Surg Infect (Larchmt). 2008 Aug;9(4):451- 11.  
11. 
Edmiston CE Jr, Daoud FC, Leaper D. Is there an evidence-based argument for embracing 
an antimicrobial (triclosan)-coated suture technology toreduce the risk for surgical-site 
infection? : A meta-analysis. Surgery. 2013 Jul;154(1):89-100. 
12. 
Z. X. Wang, C. P. Jiang, Y. Cao and Y. T. Ding. Systematic review and meta-analysis of 
triclosan-coated sutures for the prevention of surgical-site infection. Br J Surg. 2013 
Mar;100(4):465-73 
13. 
Allegranzi B, Zayed B, Bischoff P, et al. New WHO recommendations on intraoperative 
and postoperative measures for surgical site infection prevention: an evidence-based global 
perspective. Lancet Infect Dis. 2016 Dec;16(12):e288-e303. 
14. 
Ban KA, Minei JP, Laronga C, et al. American College of Surgeons and Surgical Infection 
Society: Surgical Site Infection Guidelines, 2016 Update. J Am Coll Surg. 2017 
Jan;224(1):59-74. 
15. 
Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and 
Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 
Aug 1;152(8):784-791. 
16. 
Wu X, Kubilay NZ, Ren J, Allegranzi B, Bischoff P, Zayed B, Pittet D, Li J. Antimicrobial-
coated sutures to decrease surgical site infections: a systematic review and meta-analysis. 
Eur J Clin Microbiol Infect Dis. 2017 Jan;36(1):19-32. 
17. 
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of 
surgical site infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital 
Infection Control Practices Committee. American Journal of Infection Control 1999: 27: 
97-132. http://www.cdc.gov/hicpac/pdf/guidelines/SSI_1999.pdf 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
49 
18. 
Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. A scoring method (ASEPSIS) for 
postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet 
1986: I: 311-313.http://dx.doi.org/10.1016/S0140-6736(86)90838-X 
19. 
Wilson AP, Weavill C, Burridge J, Kelsey MC. The use of the wound scoring method 
‘ASEPSIS’ in postoperative wound surveillance. Journal of Hospital Infection 1990: I6: 
297-309. PMID: 
1980502 

 LLC
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
50 
Annex 2: List of Specifications and Models 
[Investigational Product]: 
【
】 
 
 
Unidirectional 
barbed model 
SXPP1B201 
SXPP1B203 
SXPP1B204 
SXPP1B205 
SXPP1B429 
SXPP1B430 
SXPP1B431 
SXPP1B401 
SXPP1B402 
SXPP1B403 
SXPP1B404 
SXPP1B405 
SXPP1B406 
SXPP1B450 
SXPP1B407 
SXPP1B408 
SXPP1B202 
SXPP1B451 
SXPP1B452 
SXPP1B409 
SXPP1B410 
SXPP1B411 
SXPP1B412 
SXPP1B413 
SXPP1B414 
SXPP1B101 
SXPP1B102 
SXPP1B415 
SXPP1B416 
SXPP1B417 
SXPP1B418 
SXPP1B419 
SXPP1B103 
SXPP1B104 
SXPP1B105 
SXPP1B106 
SXPP1B420 
SXPP1B421 
SXPP1B107 
SXPP1B108 
SXPP1B109 
SXPP1B110 
SXPP1B422 
SXPP1B423 
SXPP1B424 
SXPP1B425 
SXPP1B111 
SXPP1B112 
SXPP1B113 
SXPP1B114 
SXPP1B115 
SXPP1B116 
SXPP1B117 
SXPP1B118 
SXPP1B119 
SXPP1B120 
SXPP1B426 
SXPP1B427 
SXPP1B428 
SXPP1B432 
SXPP1B433 
SXPP1B434 
SXPP1B453 
SXPP1B454 
SXPP1B455 
SXPP1B456 
SXPP1B457 
SXPP1B458 
 
 
Bidirectional 
barbed model 
SXPP2B422 
SXPP2B423 
SXPP2B417 
SXPP2B419 
SXPP2B418 
SXPP2B420 
SXPP2B415 
SXPP2B416 
SXPP2B200 
SXPP2B201 
SXPP2B202 
SXPP2B203 
SXPP2B426 
SXPP2B425 
SXPP2B424 
SXPP2B404 
SXPP2B413 
SXPP2B414 
SXPP2B440 
SXPP2B441 
SXPP2B442 
SXPP2B443 
SXPP2B406 
SXPP2B407 
SXPP2B408 
SXPP2B412 
SXPP2B409 
SXPP2B410 
SXPP2B411 
SXPP2B427 
SXPP2B428 
SXPP2B429 
SXPP2B430 
SXPP2B431 
SXPP2B432 
SXPP2B433 
SXPP2B401 
SXPP2B402 
SXPP2B403 
SXPP2B434 
SXPP2B400 
SXPP2B405 
SXPP2B435 
 
【
】 
 
 
Unidirectional 
barbed model 
SXMP1B408 
SXMP1B409 
SXMP1B410 
SXMP1B411 
SXMP1B412 
SXMP1B413 
SXMP1B414 
SXMP1B415 
SXMP1B416 
SXMP1B417 
SXMP1B419 
SXMP1B420 
SXMP1B421 
SXMP1B424 
SXMP1B425 
SXMP1B426 
SXMP1B427 
SXMP1B428 
SXMP1B429 
SXMP1B101 
SXMP1B102 
SXMP1B103 
SXMP1B104 
SXMP1B105 
SXMP1B106 
SXMP1B107 
SXMP1B108 
SXMP1B109 
SXMP1B110 
SXMP1B111 
SXMP1B113 
SXMP1B430 
SXMP1B431 
SXMP1B432 
SXMP1B433 
SXMP1B434 
SXMP1B435 
SXMP1B436 
SXMP1B114 
SXMP1B115 
SXMP1B116 
SXMP1B117 
SXMP1B118 
SXMP1B119 
SXMP1B120 
SXMP1B437 
SXMP1B438 
SXMP1B439 
 
 
 
 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
51 
 
Bidirectional 
barbed model 
SXMP2B405 
SXMP2B407 
SXMP2B409 
SXMP2B151 
SXMP2B404 
SXMP2B406 
SXMP2B408 
SXMP2B152 
SXMP2B150 
SXMP2B410 
SXMP2B424 
SXMP2B425 
SXMP2B426 
SXMP2B413 
SXMP2B411 
SXMP2B412 
SXMP2B414 
SXMP2B403 
SXMP2B402 
SXMP2B415 
SXMP2B416 
SXMP2B417 
SXMP2B418 
SXMP2B419 
SXMP2B420 
SXMP2B400 
SXMP2B401 
SXMP2B421 
SXMP2B422 
SXMP2B423 

 LLC，
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
52 
[Control Product]: 
【
】:
 
【
】:
 
【
】:
 
 

 LLC, 
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
53 
Annex 3: Modified Hollander Wound Evaluation Scale 
Modified Hollander Cosmesis Score 
Parameter 
Definition 
Assessment 
Yes 
No 
Step off borders  
 
Edges not on same plane  
 
As you run finger over the 
healed wound, is there a step 
or the edges? 
1 
0 
Contour irregularities 
Wrinkled skin near wound 
Is the skin near the wound 
wrinkled or puckered? 
 
1 
0 
Incision margin separation  
Gap between sides 
Is the gap between the wound 
edges at the widest point (i.e., 
scar width) >2 mm? 
1 
0 
Edge inversion  
Wound not properly 
everted 
Either of the wound edges 
invert (sink or cut) into the 
wound? 
1 
0 
Excessive inflammation  
Redness, swelling/oedema 
discharge from wound 
Is there evidence of swelling, 
redness or discharge from the 
wound?   
 
1 
0 
Overall Appearance 
 
 
Poor=1 
Good=0 
 
 
 

 LLC, 
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
54 
 
Annex 4: Vas Scale 
1. 
Postoperative Incisional Pain 
 
 
 
Score 0 means no pain; 
Score 10 means unbearable: severely affects sleep with other symptoms, or passive position; 
 
2. 
Intraoperative suture performance indicators 
Survey to be completed for the second case using 
 and 
 for each Investigator. 
 
• 
Ease to pass through tissues 
Score 0 means very easy to pass through tissues; 
Score 5 means very difficult to pass through tissues; 
• 
Surgical operation profile (including surgical “handfeel”) 
Score 0 means the best “handfeel”; 
Score 5 means the worst “handfeel”; 
• 
Suture memory 
Score 0 means no suture memory; 
Score 5 means the suture memory is very serious; 
• 
Wear resistance of suture 
Score 0 means the wear resistance is very good; 
Score 5 means the wear resistance is very bed. 
 

 LLC, 
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
55 
Annex 5: EQ-5D-5L 
 
 
 
 
 
 
 
 
 
Health Questionnaire 
 
Simplified Chinese Version for China 
 (Simplified Chinese version for China) 
 
 
 
 
 
 
 
 
 
 
 
 
China (Simplified Chinese) © 2011 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group 

 LLC, 
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
56 
Under each heading, please tick the ONE box that best describes your health today 
MOBILITY 
 
I have no problems in walking about 
□ 
I have slight problems in walking about 
□ 
I have moderate problems in walking about 
□ 
I have severe problems in walking about 
□ 
I am unable to walk about 
□ 
SELF-CARE 
 
I have no problems washing or dressing myself 
□ 
I have slight problems washing or dressing myself 
□ 
I have moderate problems washing or dressing myself 
□ 
I have severe problems washing or dressing myself 
□ 
I am unable to wash or dress myself 
□ 
USUAL ACTIVITIES (e.g. work, study, housework, family 
or leisure activities) 
 
I have no problems doing my usual activities 
□ 
I have slight problems doing my usual activities 
□ 
I have moderate problems doing my usual activities 
□ 
I have severe problems doing my usual activities 
□ 
I am unable to do my usual activities 
□ 
PAIN/DISCOMFORT 
 
I have no pain or discomfort 
□ 
I have slight pain or discomfort 
□ 
I have moderate pain or discomfort 
□ 
I have severe pain or discomfort 
□ 
I have extreme pain or discomfort 
□ 
ANXIETY/DEPRESSION 
 
I am not anxious or depressed 
□ 
I am slightly anxious or depressed 
□ 
I am moderately anxious or depressed 
□ 
I am severely anxious or depressed 
□ 
I am extremely anxious or depressed 
□ 
2 
China (Simplified Chinese) © 2011 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group 
 
 

 LLC, 
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
57 
 
• We would like to know how good or bad your health is TODAY. 
• This scale is numbered from 0 to 100. 
• 100 means the best health you can imagine. 
0 means the worst health you can imagine. 
• Mark an X on the scale to indicate how your health is TODAY. 
• Now, please write the number you marked on the scale in the box below. 
The best health you 
can imagine 
 
YOUR HEALTH TODAY = 
 
 
 
The worst health 
you can imagine 
3 
China (Simplified Chinese) © 2011 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group 
 
 

 LLC, 
 
ESC-201702 
[PROTOCOL VERISON AND DATE] V2.0/2019-09-30 
CONFIDENTIAL 
 
58 
Annex 6: Asepsis Score (Example) 
Incision Characteristics 
Proportion of Wound Affected 
0 
<20 
20-39 
40-59 
60-79 
>80 
Serous exudate 
0 
1 
2 
3 
4 
5 
Erythema 
0 
1 
2 
3 
4 
5 
Purulent exudate 
0 
2 
4 
6 
8 
10 
Separation of deep tissues 
0 
2 
4 
6 
8 
10 
Points are scored for daily wound inspection. 
 
Additional Treatment 
Points 
Antibiotics 
10 
Drainage of pus under local anesthesia 
5 
Debridement of wound (general anesthesia) 
10 
Serous discharge* 
Daily 0-5 
Erythema* 
Daily 0-5 
Purulent exudate* 
Daily 0-10 
Separation of deep issues* 
Daily 0-10 
Isolation of bacteria 
10 
Stay as inpatient prolonged over 14 days 
5 
* Given score only on five of seven days. Highest weekly score used. 
 
Category of Infection 
Total Score** 
Definition 
0-10 
Satisfactory healing 
11-20 
Disturbance of healing 
21-30 
Minor wound infection 
31-40 
Moderate wound infection 
>40 
Severe wound infection 
** When calculating the total score, scores of independent incision characteristics and additional treatments 
should be added.