A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Effect of GYNECARE INTERCEED™ Absorbable Adhesion Barrier in Preventing the Abdominal Incision Adhesions
Phase: PHASE3
Conditions: Subjects Scheduled to Undergo Laparoscopic Radical Resection of Rectal Carcinoma With Preventive Ileostomy
Sponsor: Ethicon, Inc.

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Ethicon SARL, INTERCEED 
ESC-201701 
APR 27 2020, VERSION: 5.0 
 
 Confidential 
 
2 
 
Revision Record 
 
Revised 
version 
Revision date 
Description of changes 
1.1 
Nov 1 2017 
 
1. The change of the name of study device: 
change all “GYNIECARE INTERCEEDTM 
Absorbable Adhesion Barrier” to 
“INTERCEEDTM Absorbable Adhesion 
Barrier”. 
2. Use the abbreviation of the study device in 
the text of the protocol: change all 
“GYNIECARE INTERCEEDTM Absorbable 
Adhesion Barrier” to “INTERCEEDTM”. 
3. The change of study site: delete “Jiangsu 
Province Hospital” and add “The First 
Affiliated Hospital of Nanchang University”, 
“Xiangya Hospital Central South University” 
and “The affiliated Hospital of Xuzhou 
Medical University” into the list. 
4. Other changes: Study Objectives: “The 
primary objective of this study is to evaluate 
the efficacy and safety of INTERCEEDTM in 
reducing the incidence of adhesions at the 
abdominal incision site in patients 
undergoing laparoscopic colorectal 
surgery.” Changed to “The primary objective 
of this study is to evaluate the efficacy and 
safety of INTERCEEDTM Absorbable 
Adhesion Barrier (hereafter called 
INTERCEED™) in reducing the incidence of 
adhesions at the abdominal incision site in 
patients undergoing laparoscopic colorectal 
surgery.” 
2.0 
Mar 7 2018 
1. The change of study site: delete “Tangdu 
Hospital” and add “Shanghai Tenth People’s 
Hospital” into the list. 
2. The change of the number of study site in the 
synopsis: from 8 to 10. 
3. Other changes: Section 13.1, add “All Aes 
need to be recorded in the EDC system in 2 
weeks”. 
3.0 
Jun 25 2018 
1. The follow-up period of evaluating the 
Primary Endpoint (Phase 2 operation): from 
6-9 months after phase 1 operation to 3-7 
months after phase 1 operation. 
2. The change of study site: add “The Second 
Xiangya Hospital of Central South 

Ethicon SARL, INTERCEED 
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3 
 
University” , “The First Affiliated Hospital of 
Zhengzhou University” and “Ruijin Hospital” 
into the list. 
3. The change of the number of study site in the 
synopsis: from 10 to 13 
4. Exclusion Criteria: from “• Patient with a 
history of mechanical bowel obstruction” to 
“Patient with a history of mechanical bowel 
obstruction, but except the mechanical 
bowel obstruction caused by the colorectal 
cancer treated in the Phase I operation” 
5. Visit: Add “Visit 7” and revise the description 
of “study completion” 
6. Adverse event: Postoperative pain, fever and 
laboratory abnormalities is expected and will 
not be documented as an adverse event 
unless the Investigator considers the pain or 
fever to exceed that normally anticipated 
following the surgery or related to study 
devices. Also, the adverse event, not 
including the serious adverse event and 
ileus event, which is “not relative” or 
“unlikely related” to the study device and 
occurred 1. between 30 days after Phase 1 
operation and the hospitalization for Phase 2 
operation or 2. between Visit 6 and Visit 7  
should not be documented. 
7. Serious adverse event: The rehospitalization 
events only for receiving the scheduled 
chemotherapy/radiotherapy between Phase 1 
operation and Phase 2 operation will not be 
documented as an adverse event.  
4.0 
Jun 25 2019 
1. The follow-up period of evaluating the 
Primary Endpoint (Phase 2 operation): from 
3-7 months after phase 1 operation to 3-9 
months after phase 1 operation. 
2. The change of study site: withdraw “Beijing 
Cancer Hospital” from the list. 
3. The change of the number of study site in the 
synopsis: from 13 to 12. 
4. Withdrawal of Subjects: from “The subject 
undergoes a second abdominal operation 
that doesn’t meet the definition of Phase 2 
operation (see Section 3.2) within the 
follow-up period, such as:” to “The subject 
undergoes a second abdominal operation 
that doesn’t meet the definition of Phase 2 
operation (see Section 3.2) within the 
follow-up period and without the image data 
as described in the Section 7.1.2.. The 

Ethicon SARL, INTERCEED 
ESC-201701 
APR 27 2020, VERSION: 5.0 
 
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4 
 
abdominal operation included but not limited 
to:” 
5. Overall duration of clinical trial: from 42 to 
47.  
6. Maximum Number of Subjects in Each 
Clinical Trial Institution: delete ”The number 
of patients recruited in any site should not 
exceed 54.” . 
7. Email: from”qzhu15@its.jnj.com” to 
“RA-JNJSG-InterceedCN@ITS.JNJ.com”. 
8. Ethical concern: Delete “The control product 
should ensure the safety for the subjects to 
the full extent.”. 
9. Reporting Procedure, Contact Information: 
Delete “From randomization of the subject, 
all adverse events related to the subject’s 
participation in this study should be followed 
up until the event is resolved, or if the event 
causes the permanent damage, it should be 
followed up until the event is stable and the 
clinical outcome is determined.”. 
10. Study Design: delete ” from the ostomy site 
abdominal wall opening before submersion 
of the bowel loop into the peritoneal cavity 
and abdominal wound closure”. 
11. Contents of Clinical Trial: from “patients” to 
“subjects”. 
12. Secondary Endpoint: form “Complaints of 
study product” to “Defects of study 
product”. 
13. Measures to Reduce and Avoid Bias: from 
“All medical records (source documents) 
documenting the adhesion barrier 
application procedure through hospital 
discharge and all follow-ups will not be 
blinded because the operation record will 
indicate whether the anti-adhesion product is 
applied.” to “All medical records (source 
documents) documenting the adhesion 
barrier application procedure through 
hospital discharge and all follow-ups will not 
be blinded, because the operation record will 
not indicate whether the anti-adhesion 
product is applied.”. 
14. Criteria and Procedure of Withdrawal of 
Subjects from Study: “Discontinuation” to 
“Withdrawal”. 
15. Visit 1: add “adverse events ”. 
16. Device Defect: from “The investigator should 

Ethicon SARL, INTERCEED 
ESC-201701 
APR 27 2020, VERSION: 5.0 
 
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record all adverse events occurred and 
device defects found in the process of 
clinical trial” to “The investigator should 
record all adverse events required in 
protocol and device defects found in the 
process of clinical trial” . 
17. Reporting Procedure, Contact Information:  
“The investigator must submit the serious 
adverse events occurred in the study and the 
device defects that may cause serious 
adverse event to the sponsor and CFDA (or 
designated person) immediately after being 
informed of the event” to “The investigator 
must submit the serious adverse events 
occurred in the study and the device defects 
that may cause serious adverse event to the 
sponsor and the regulatory authorities at 
every level (or designated person) 
immediately after being informed of the 
event” 

Ethicon SARL, INTERCEED 
ESC-201701 
APR 27 2020, VERSION: 5.0 
 
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5.0 
27 Apr 2020 
1. The placement of drainage tube: from “The 
drainage tube (if applicable) must be placed 
on the left side of the patient and is 
recommended to be lateral to the left 
midclavicular line.” to “The drainage tube (if 
applicable) could be placed on either side of 
the patient according to the standard of care 
of the participating site and should be at the 
discretion of the investigator away from the 
target incision as much as possible.” 
2. Study design: Add “An ad-hoc interim 
analysis is proposed based on feedback 
received from the investigators who 
observed very low rate of adhesions at the 
second procedure for ostomy reversal. The 
ad-hoc interim analysis is planned to be 
performed while at least 61% of the total 
number of participants with evaluable 
primary endpoints are available. If the 
conditional power (CP) is ≤ 60%, the 
observed adhesion rate difference 
magnitude is much less than the assumed 
difference magnitude of 0.25, therefore, the 
study will be terminated due to low adhesion 
rate and small effect size between 
INTERCEED and control arms. Otherwise, 
the study will continue until the study 
completion as planned.” 
3. Update “Criteria and Reason for Terminating 
the Trial based on the Statistical Results” 
section as per interim analysis plan. 
4. Update “Reporting Procedure of Deviation 
from Original Statistical Plan” section as per 
interim analysis plan. 
5. Update “Likelihood Analysis of Failure” 
section as per feedback from the investigator 
and interim analysis plan. 
6. Serious Adverse Event: from “The 
rehospitalization events only for receiving 
the scheduled chemotherapy/radiotherapy 
between Phase 1 operation and Phase 2 
operation will not be documented as an 
adverse event.” to “The rehospitalization 
events after Phase 1 operation only for 
receiving the chemotherapy/radiotherapy 
which planned after the diagnosis of the 
primary disease will not be documented as 
an adverse event”. 

Ethicon SARL, INTERCEED 
ESC-201701 
APR 27 2020, VERSION: 5.0 
 
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7 
 
7. Removed the Approval Page. 
8. Updated Expected overall duration of clinical 
trial and reasons for determination: from 
“The expected overall duration is about 47 
months” to “The expected overall duration is 
about 60 months” 
 

Ethicon SARL, INTERCEED 
ESC-201701 
APR 27 2020, VERSION: 5.0 
 
 Confidential 
 
8 
 
 
 
A Prospective, Multicenter, Randomized Controlled Study to 
Evaluate the Effect of INTERCEED™ Absorbable Adhesion 
Barrier in Preventing the Abdominal Incision Adhesions 
Protocol Number:  ESC-201701 
 
Approval: Refer to TV-eFRM-02922 Protocol Approval Form 
 
 
  
 
COMPLIANCE STATEMENT 
 
This study will be conducted in compliance with the Declaration of Helsinki as well as all applicable local regulations. 

Ethicon SARL, INTERCEED 
ESC-201701 
APR 27 2020, VERSION: 5.0 
 
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9 
 
TABLE OF CONTENTS 
SYNOPSIS ......................................................................................................... 12 
1. SPONSOR INFORMATION .......................................................................... 16 
2. LIST OF CLINICAL TRIAL INSTITUTIONS AND INVESTIGATORS ........... 16 
3. OBJECTIVE AND CONTENTS OF CLINICAL TRIAL .................................. 17 
3.1. Objective of Clinical Trial .................................................................... 17 
3.2. Contents of Clinical Trial ..................................................................... 17 
4. BACKGROUND INFORMATION OF CLINICAL TRIAL ............................... 18 
4.1. Introduction to the Condition ............................................................... 18 
4.1.1. Explanation for the Condition ................................................. 18 
4.1.2. Therapeutic Option and Prognosis ......................................... 18 
4.2. Application of Investigational Product and Control Product ................ 18 
4.3. Product registration and the reason for clinical trial registration in 
China .................................................................................................. 24 
5. Features, structural composition, operation principle, mechanism of 
action and study population ............................................................................ 24 
5.1. Features ............................................................................................. 24 
5.2. Structural Composition, Operation Principle and Mechanism of 
Action ................................................................................................. 25 
5.3. Study Population ................................................................................ 25 
6. INDICATIONS AND CONTRAINDICATIONS, PRECAUTIONS ................... 26 
6.1. Indications: ......................................................................................... 26 
6.2. Contraindications: ............................................................................... 26 
6.3. Precautions: ....................................................................................... 26 
7. OVERALL DESIGN ....................................................................................... 27 
7.1. Trial Design ........................................................................................ 27 
7.1.1. Trial Objective ........................................................................ 27 
7.1.2. Trial Endpoint ......................................................................... 27 
7.1.3. Trial Method Selection and Its Rationale................................ 30 
7.1.4. Measures to Reduce and Avoid Bias ..................................... 30 
7.1.5. Selection of Subjects: ............................................................ 31 
7.1.6. Efficacy Evaluation Method .................................................... 35 
7.1.7. Safety Evaluation Method ...................................................... 35 
7.2. Study Process .................................................................................... 35 
7.2.1. Study Flowchart ..................................................................... 35 
7.2.2. Standard Operating Procedures of Medical Device ............... 37 
7.2.3. Study Procedure .................................................................... 38 
7.3. Monitoring Plan................................................................................... 44 
8. STATISTICAL CONSIDERATIONS .............................................................. 45 
8.1. Statistical Design, Method and Analysis Procedure ........................... 45 
8.2. Calculation of Sample Size ................................................................. 46 

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8.2.1. Total Sample Size: 220 patients. ........................................... 46 
8.2.2. Minimum and Maximum Number of Subjects in Each 
Clinical Trial Institution and Reasons for determination ..................... 46 
8.3. Significance Level and Power of Clinical Trial .................................... 46 
8.4. Expected Drop-out Rate ..................................................................... 46 
8.5. Criterion of Acceptability/Unacceptability of Clinical Trial Result ........ 47 
8.6. Criteria and Reason for Terminating the Trial based on the 
Statistical Results ............................................................................... 47 
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 .................................... 48 
8.8. Reporting Procedure of Deviation from Original Statistical Plan ......... 48 
8.9. Selection Criteria and Reason of Subjects Included in the Analysis ... 48 
9. Data management ........................................................................................ 48 
10. FEASIBILITY ANALYSIS.............................................................................. 49 
10.1. Likelihood Analysis of Success .......................................................... 49 
10.2. Likelihood Analysis of Failure ............................................................. 49 
11. QUALITY CONTROL OF CLINICAL TRIAL ................................................. 49 
12. CLINICAL TRIAL-INVOLVED ETHICAL ISSUES AND INFORMED 
CONSENT .......................................................................................................... 50 
12.1. Ethical Concerns ................................................................................ 50 
12.2. Approval of Trial Protocol ................................................................... 50 
12.3. Process of Informed Consent and Text of Informed Consent Form ... 50 
12.3.1. Process of Informed Consent ............................................... 50 
12.3.2. Text of Informed Consent Form ........................................... 51 
13. REGULATIONS OF ADVERSE EVENT AND DEVICE DEFECT 
REPORTING....................................................................................................... 51 
13.1. Adverse event .................................................................................... 51 
13.2. Serious Adverse Event ....................................................................... 52 
13.3. Device Defect ..................................................................................... 52 
13.4. Reporting Procedure, Contact Information ......................................... 52 
14. DEVIATION FROM CLINICAL TRIAL PROTOCOL AND REGULATIONS 
FOR CLINICAL TRIAL PROTOCOL AMENDMENT .......................................... 53 
15. DIRECT ACCESS TO SOURCE DATA AND DOCUMENT .......................... 54 
16. FINANCES AND INSURANCE ..................................................................... 54 
17. CONTENTS THAT THE CLINICAL TRIAL REPORT SHOULD COVER ..... 54 
18. CONFIDENTIALITY ...................................................................................... 55 
19. AGREEMENT ON THE PUBLICATION OF TRIAL RESULTS ..................... 55 
20. RESPONSIBILITIES THAT EACH PARTY SHOULD BEAR ....................... 56 
20.1. Responsibilities of the sponsor ........................................................... 56 
20.2. Responsibilities of Clinical Trial Institution and Investigator ............... 56 

Ethicon SARL, INTERCEED 
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20.3. Responsibilities of other interested parties ......................................... 58 
Statement of Investigator ................................................................................. 59 
Appendix 1: ....................................................................................................... 60 
References ........................................................................................................ 60 
Appendix 2: List of models/specifications ..................................................... 62 
 

Ethicon SARL, INTERCEED 
ESC-201701 
APR 27 2020, VERSION: 5.0 
 
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SYNOPSIS 
 
Study Title 
A Prospective, Multicenter, Randomized Controlled Study to 
Evaluate the Effect of Absorbable Adhesion Barrier in Preventing 
the Abdominal Incision Adhesions 
Study 
Objectives 
The primary objective of this study is to evaluate the efficacy and 
safety of INTERCEEDTM Absorbable Adhesion Barrier (hereafter 
called INTERCEED™) in reducing the incidence of adhesions at 
the abdominal incision site in patients undergoing laparoscopic 
colorectal surgery.  
Number 
of 
Study Sites 
12 Sites 
Number 
of 
Subjects 
220 Subjects 
Study Design  
This is a prospective, randomized controlled study. The study 
population will include 220 subjects scheduled to undergo 
laparoscopic radical resection of rectal carcinoma with preventive 
ileostomy (Phase 1 operation).  
During the Phase 1 operation, when the definite decision to create 
a temporary ostomy is made, patients will be randomized in 1:1 
ratio to either the treatment arm (INTERCEED™) or the control 
arm (standard of care treatment: no adhesion barrier, no placebo). 
In subjects assigned to the treatment arm, the INTERCEED™ must 
be applied beneath the target incision site (the midline incision 
mainly for the removal specimen). 
The subjects will return 3-9 months after the phase 1 operation 
(colorectal resection with temporary ileostomy) for phase 2 
operation, to have their diverting ostomy taken down (ileostomy 
reversal).  
During the phase 2 operation (ileostomy reversal), the incidence, 
extent and severity of adhesions will be evaluated through the 
laparoscope. 
An ad-hoc interim analysis is proposed based on feedback 
received from the investigators who observed very low rate of 
adhesions at the second procedure for ostomy reversal. The 
ad-hoc interim analysis is planned to be performed while at least 61% 
of the total number of participants with evaluable primary endpoints 

Ethicon SARL, INTERCEED 
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APR 27 2020, VERSION: 5.0 
 
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13 
 
are available. If the conditional power (CP) is ≤ 60%, the observed 
adhesion rate difference magnitude is much less than the assumed 
difference magnitude of 0.25, therefore, the study will be terminated 
due to low adhesion rate and small effect size between INTERCEED 
and control arms. Otherwise, the study will continue until the study 
completion as planned. 
Study 
Endpoints 
The primary endpoint is defined as the proportion of subjects free 
of adhesions at the target incision site in each study group.  
The assessment of adhesions will be conducted during the second 
laparoscopy for ileostomy reversal (phase 2 operation).  
Secondary endpoints of the study include: a) extent and 
severity of adhesions at the target incision site and four abdominal 
quadrants; b) incidence of mechanical ileus; c) Incidence of 
surgical site infections; d) Incidence of postoperative all-layer 
wound dehiscence; e) incidence of delayed wound healing; f) any 
adverse events and g) study product defects. 
Test Product 
This product is a sterile, single-use-only, absorbable, off-white 
knitted fabric; Size 7.6cm x 10.2cm.  
 
Inclusion 
Criteria 
• 
Subjects ≥ 18 years of age who require laparoscopic 
colorectal resection with the formation of a temporary 
diverting loop ileostomy and a planned closure of diverting 
ileostomy within 3 to 9 months;  
• 
The subjects should be willing to participate in the study, 
comply with study requirements, follow-up schedule, and 
give written informed consent prior to any study-related 
procedures; 
• 
The 
target 
incision 
length 
≤ 
8cm 
allowing 
the 
INTERCEED™ (product length 10.2cm) to overlap at least 
1cm beyond each pole of the incision; 
• 
The subject is believed to have life expectancy ≥ 12 months 
after 
Phase 
1 
operation, 
based 
on 
investigators’ 
assessment. 
Exclusion 
Criteria 
• 
Female patients who are pregnant or lactating at the time of 
screening; 
• 
Patient with a history of mechanical bowel obstruction, but 
except the mechanical bowel obstruction caused by the 
colorectal cancer treated in the Phase I operation; 
• 
Subjects with history of mid and lower abdominal region or 

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pelvic surgery; 
• 
Patients for whom it is known that loop ileostomy closure 
within 3 to 9 months is not feasible 
• 
Patients with a history of active intra-abdominal infection 
such as peritonitis or abdominal abscess; 
• 
Patients with a history of intestinal fistulae; 
• 
Patients with a history of endometriosis; 
• 
Intended use of intraoperative lavage/irrigation with any 
anti-adhesion solutions other than saline (e.g., dextran, 
heparin, corticosteroids, icodextrin) or an adhesion barrier 
other than INTERCEED™; 
• 
Use of immune system suppressants deemed by the 
investigator to interfere with wound healing; 
• 
Impaired immune system function or coagulation disorders 
deemed by the surgeon to interfere with wound healing; 
• 
Bevacizumab use within 30 days prior to surgery; 
• 
Subjects with any intra-operative findings identified by the 
surgeon that may preclude conduct of the study 
procedures; 
• 
Patients with evidence of distant metastasis of the primary 
colorectal cancer; 
• 
Patients who underwent abdominal radiotherapy before 
Phase 1 operation; 
• 
Adhesions 
(Grade 
2-3 
adhesion[1]) 
and/or 
gross 
contamination (e.g., caused by tumor perforation) present 
in the abdominal cavity at the Phase 1 operation; 
• 
The rectal carcinoma radical resection (R0 resection) + 
preventive ileostomy are not performed in Phase 1 
operation; 
• 
Expected resection of other organs (e.g., bladder, uterus, 
etc.) during Phase 1 operation; 
• 
Use 
of 
topical 
haemostatic 
products, 
local 
chemotherapeutic products or other drugs and/or medical 
device in abdominal/pelvic cavity which may impact the 
study primary endpoint judged by the investigator; 
• 
Patient is participating in other investigational drug or 
device study within 30 days or 5 half-lives of an 
investigational drug;  
• 
A known history of severe multiple drug allergies or known 
allergy to cellulose or cellulose derived products; 
• 
Any medications, treatments and/or implanted devices 
(except INTERCEED™) that on investigator’s opinion may 

Ethicon SARL, INTERCEED 
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be adhesiogenic or may potentially affect the observation of 
postoperative adhesions; 
• 
Any physical or psychological conditions that at discretion 
of investigators may impair study participation;  
• 
A medical condition or other serious conditions that will 
interfere with compliance and/or ability to complete this 
study protocol; or 
• 
Any other situation or reason that at discretion of 
investigators is unsuitable for study participation. 
 

Ethicon SARL, INTERCEED  
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1. SPONSOR INFORMATION 
(1) Name of sponsor 
Ethicon SARL 
(2) Address of sponsor 
Puits Godet 20, Neuchatel CH-2000, Switzerland.  
(3) Contact of sponsor 
Email: rkochar1@its.jnj.com 
(4) Related qualification documents of sponsor 
See the CE certification attached to the protocol 
(5) Name, address, contact and related qualification documents of agent 
Johnson & Johnson Medical (Shanghai) Ltd. 
Section C, Floor 1,2,3, No. 439, Futuxi Road, China (Shanghai) free trade zone. 
Email: RA-JNJSG-InterceedCN@ITS.JNJ.com  
Tel: +86021-33378888 
Address: Building A, Xinyan Mansion, No. 65, Guiqing Road, Xuhui District, Shanghai, China. 
See the business license attached to the protocol. 
 
2. LIST OF CLINICAL TRIAL INSTITUTIONS AND INVESTIGATORS  
Code of 
clinical 
trial 
institution 
Name of clinical 
trial institution 
Investigator 
(signature) 
Title 
Contact 
1* 
Beijing Friendship 
Hospital, Capital 
Medical University 
Zhongtao 
Zhang 
Director 
010-63014411 
2 
Peking University 
People's Hospital 
Yingjiang Ye 
Director 
010-88326666 
3 
Chinese PLA 
General Hospital 
Lin Chen 
Director 
010-68182255 
5 
The First Hospital 
of Jilin University 
Jian Suo 
Director 
0431-88782222 
6 
Changhai Hospital  
Wei Zhang 
Director 
021-31166666 
7 
Shanghai Tenth 
People’s Hospital 
Donglei Zhou 
Director 
021-66303643 
8 
The First Affiliated 
Hospital of 
Nanchang 
University  
Zhengrong Li 
Director 
0791-88692748 

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9 
Xiangya Hospital 
Central South 
University 
Zhikang Chen 
Director 
0731-84328888 
10 
The affiliated 
Hospital of Xuzhou 
Medical University 
Jun Song 
Director 
0516-85609999 
11 
The Second 
Xiangya Hospital of 
Central South 
University 
Hongliang Yao 
Director 
0731-85295888 
 
12 
The First Affiliated 
Hospital of 
Zhengzhou 
University 
Weitang Yuan 
Director 
0371-66913114 
 
13 
Ruijin Hospital 
Aiguo Lu 
Director 
021-64370045 
 
*Information of leading site and principal investigator  
 
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 INTERCEED™ in 
reducing the incidence of adhesions at the abdominal incision site in patients undergoing 
laparoscopic colorectal surgery.  
3.2. Contents of Clinical Trial 
The study population will enroll 220 subjects schedulled to undergo laparoscopic colorectal 
carcinoma radical resection with preventive ileostomy. The enrolled subjects will be randomly 
divided in two groups in a 1:1 ratio: the study group and control group, of which the 
INTERCEED™ is applied in the study group, and no adhesion barrier for subjects in the control 
group. 
In this study, a follow-up period of 9 months will be required for the eligible subjects. The primary 
endpoint is defined as the proportion of subjects free of adhesions at the target incision site in 
each study group. The target incision site in this study is a midline incision mainly for removal the 
specimen. The assessment of adhesions will be conducted during the second laparoscopy for 
ileostomy reversal.  The study hypothesis is that the occurrence of postoperative target incision 
site adhesions in the study group using INTERCEED™ would be lower than that in the control 
group. 
The Phase 1 operation is defined as laparoscopic rectal carcinoma radical resection (R0 resection) 
with preventive terminal ileostomy; and the Phase 2 operation is defined as ileostomy reversal 
and laparoscopic exploration between 3 months to 9months after Phase I operation. 
Secondary endpoints of the study include: a) extent and severity of adhesions at the target 
incision site and four abdominal quadrants; b) incidence of mechanical ileus; c) Incidence of 
surgical site infections; d) Incidence of postoperative all layer wound dehiscence; e) 

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incidence of delayed wound healing; f) any adverse events and g) study product defects. 
 
4. BACKGROUND INFORMATION OF CLINICAL TRIAL 
4.1. Introduction to the Condition 
4.1.1. Explanation for the Condition 
Postoperative adhesion formation is a common complication after abdominal and pelvic 
operations. Abdominal and pelvic adhesions may be present after most of the operations. It may 
cause serious complications such as ileus, chronic pain and female infertility, etc., which may 
have strong impact on the patient’s quality of life, resulting in significant medical and health 
resources utilization [2-5]. The incidence of postoperative adhesions is currently considered a 
complex process related to the injury of the intraperitoneal endothelial layers of visceral and 
abdominal wall, starting to form within a week after the operation [6]. The early epidemiological 
data showed that the incidence of adhesions after the abdominal and pelvic operations might be 
up to 95% in some cases [7]. Other recent controlled studies also demonstrated that their 
incidence could range between 60 and 85% [8-12]. The formation of adhesions after surgical 
procedures may be suspected based on clinical symptoms but can only be definitely confirmed by 
looking inside the peritoneal cavity either during subsequent laparoscopic or open procedure. 
Routine assessment of incidence of adhesions after surgery is not typical because it requires a 
“second-look” procedure. However, there are few surgical procedures where a second look 
laparoscopy is part of the planned treatment process, e.g. a phased bowel reconstruction such 
the reversal of temporary loop ileostomy or split colostomy.  
4.1.2. Therapeutic Option and Prognosis 
Currently, several products available for application in abdominal/pelvic cavity to prevent the 
occurrence of postoperative adhesions, such as INTERCEED™, Seprafilm, etc. Multiple studies 
have shown that applying these products to the incision site or wrapping around the visceral 
organs in the abdominal and pelvis operations can effectively reduce the occurrence of abdominal 
adhesions [7-11]. 
 
4.2. Application of Investigational Product and Control Product 
INTERCEED™ (Oxidized Regenerated Cellulose) is a sterile, single-use-only, absorbable 
off-white knitted fabric prepared by the controlled oxidation of regenerated cellulose. It has been 
applied in clinical practice for many years. It already has some clinical and non-clinical evidences. 
Based on the existing clinical literatures, the application of the investigational product is as follows 
(Table 1): 
Table 1 Clinical data of INTERCEED™ 
Author 
Method 
Result 
Conclusion 
Sekiba 
K[13] 
INTERCEED™ (TC7) was 
evaluated in a randomized, 
multicenter clinical study. 
Significantly more adhesions 
were observed at second 
laparoscopy on the control 
The author 
conclude that 
INTERCEED™ 

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Sixty-three infertility patients 
had bilateral pelvic sidewall 
adhesions removed at 
laparotomy. One pelvic 
sidewall was covered by 
INTERCEED™ (TC7) and the 
other was left uncovered. The 
deperitonealized areas (N = 
205) of all sidewalls were 
divided into three groups: 
less than 100 mm2, N = 72; 
100-1000 mm2, N = 95; and 
more than 1000 mm2, N = 
38. The effectiveness of 
INTERCEED™ (TC7) was 
evaluated at laparoscopy 
10-98 days after laparotomy. 
pelvic sidewalls (48 of 63, 
76%) than on the treated sides 
(26 of 63, 41%) (P less 
than .0001). The 
INTERCEED™ (TC7)-treated 
sidewalls also had significantly 
less area involved with 
adhesions at laparoscopy (P 
less than .05, P less than .001, 
and P less than .001 in the 
three groups, respectively). 
Twenty-eight women with 
severe endometriosis also had 
significantly more adhesions 
on the control side (23 of 28, 
82%) than on the treated side 
(14 of 28, 50%) (P less 
than .05). 
(TC7) effectively 
reduced the 
incidence and 
extent of 
postoperative 
adhesions, even in 
patients with 
severe 
endometriosis. 
Azziz 
R[14] 
Prospective, multicenter, 
randomized, blinded, 
controlled study 
involving134 patients. 
Treatment side 
INTERCEED™  
Barrier; control side good 
surgical technique. 
Evaluation method 
at second look laparoscopy, 
10 days to 14 weeks 
post-surgery. 
Measurements include 
incidence of adhesions and 
extent of 
adhesions. 
2nd-look laparoscopy: 
Adhesions present:  
INTERCEED™  10/134* 
Control side 46/134 
Both sides 56/134 
None 22/134 
*p<0.0001 
INTERCEED™ 
Barrier is twice as 
effective in 
preventing 
the incidence of 
adhesions as good 
surgical technique 
alone. 
Li TC, 
Cooke 
ID. [15] 
A prospective, randomised, 
controlled study was 
conducted. Twenty-eight 
women who underwent pelvic 
microsurgery for infertility or 
for chronic pelvic pain and 
who had bilateral pelvic 
adhesions and 
deperitonealised areas 
following adhesiolysis. 
Following microsurgical 
adhesiolysis, one side of the 
The use of INTERCEED™  
resulted in a significant 
reduction of adhesion 
reformation over and above 
that achieved by conventional 
microsurgical techniques with 
hydrocortisone as an adjuvant. 
INTERCEED™ , 
an absorbable 
adhesion barrier, 
is of value in the 
prevention of 
adhesion 
reformation and 
may be used in 
conjunction with 
hydrocortisone 
instilled 
intraperitoneally at 

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pelvis was randomised to 
have its deperitonealised 
areas covered with 
INTERCEED™ , whereas the 
contralateral side served as 
the control. A second look 
laparoscopy was carried out 
3 to 14 weeks after 
microsurgery to evaluate 
adhesion reformation. 
the conclusion of 
microsurgery. 
 
Tinelli A, 
Malvasi 
A, Guido 
M, Tsin 
DA, 
Hudelist 
G, Hurst 
B, Stark 
M, 
Mettler L. 
[8] 
Prospective blinded 
observational study was 
conducted. A total of 694 
women undergoing 
laparoscopic or abdominal 
myomectomy were 
randomized for placement of 
oxidized regenerated 
cellulose absorbable 
adhesion barrier to the 
uterine incision or for control 
subjects without barriers. The 
presence of adhesions was 
assessed in 546 patients who 
underwent subsequent 
surgery. 
There was a higher rate of 
adhesions in laparotomy 
without barrier (28.1%) 
compared with laparoscopy 
with no barrier (22.6%), 
followed by laparotomy with 
barrier (22%) and laparoscopy 
with barrier (15.9%). 
Additionally, the type of 
adhesions were different, filmy 
and organized were 
predominant with an adhesion 
barrier, and cohesive 
adhesions were more common 
without an adhesion barrier. 
Oxidized 
regenerated 
cellulose reduces 
postsurgical 
adhesions. 
Cohesive 
adhesions 
reduction was 
noted in 
laparoscopy. 
Chapa H 
O, 
Venegas 
G.[9] 
This was a retrospective 
study of patients in whom an 
absorbable adhesion barrier 
was/was not used at their 
primary CS. Mean and 
excessive blood loss, the 
need for adhesiolysis, and 
postoperative fever were 
compared between those in 
whom a barrier was used at 
first CS and those in whom a 
barrier was not used. Visceral 
injury at repeat cesarean was 
also compared between the 
two groups. 
No statistically significant 
difference in mean blood loss 
was noted between the two 
groups. However, significantly 
more patients in whom a 
barrier was not used had 
excessive intraoperative blood 
loss (barrier group, 1/53 
[1.9%]; no-barrier group, 6/59 
[10.1%]; P = 0.04). All seven 
cases of excessive blood loss 
had adhesiolysis. Significantly 
more patients in the no-barrier 
group underwent adhesiolysis 
(no-barrier group, 35/59 
[59.3%]; barrier group, 7/53 
[13.2%]; P = 0.03). No 
statistical difference in 
postoperative metritis was 
noted (1/59 [1.8%] in the 
barrier group and 1/59 [1.7%] 
Those in whom a 
barrier was not 
used at primary 
CS were more 
likely to have 
adhesiolysis and 
excessive blood 
loss (.1250 mL) at 
repeat CS. No 
significant 
difference in 
postoperative 
metritis/fever was 
noted between 
groups. Adhesion 
barrier at primary 
CS may reduce 
some aspects of 
maternal morbidity 
at repeat CS. 

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in the no-barrier group; P = 
0.99). Only one 
deserosalization of the bladder 
dome occurred in a patient in 
the no-barrier group. 
Chapa 
HO, 
Venegas 
G, 
Vanduyn
e CP, 
Antonetti 
AG, 
Sandate 
JP, Silver 
L.[16] 
A retrospective, two-arm 
cohort, chart review of 
primary and subsequent first 
repeat cesarean sections 
from January 1, 
2006-December 31, 2009 
was performed. Exclusion 
criteria were incomplete 
operative report, history of 
prior abdominal-pelvic 
surgery, pelvic inflammatory 
disease, chorioamnionitis, 
emergency cesarean delivery 
or use of corticosteroids 
within 2 weeks. Adhesion 
incidence/severity as well as 
skin incision to newborn 
delivery times were analyzed. 
Effects of peritoneal closure 
and suture types were 
examined. 
Of 262 primary cesareans 
performed, 43% (N= 112) had 
repeat cesarean section. With 
barrier, 74% had no adhesions 
at repeat surgery, versus 22% 
in the no barrier group (p = 
0.011). Eleven percent had 
grade 2 adhesions with barrier, 
while 64% had grade 2-3 in the 
no barrier group (p = 0.012). 
The barrier group had no grade 
3 adhesions. Those with 
parietal peritoneal closure had 
less incidence (p = 0.02) and 
mean adhesion severity (p = 
0.03); no significant difference 
was found per suture type. No 
statistical difference in time 
from skin incision to newborn 
delivery was noted between 
primary and barrier group (p = 
0.006); those without barrier 
had a statistically longer 
delivery interval (p = 0.35). 
Use of an 
absorbable 
adhesion 
baóóórrier reduces 
the incidence and 
severity of 
adhesions at 
cesarean. 
Haney 
AF, 
Hesla J, 
Hurst 
BS, 
Kettel 
LM, 
Murphy 
AA, Rock 
JA, 
Rowe G, 
Schlaff 
WD.[17] 
A multicenter, nonblinded, 
randomized clinical trial was 
performed. Each barrier was 
allocated randomly to the left 
or right sidewall of every 
patient. Thirty-two women 
with bilateral pelvic sidewall 
adhesions undergoing 
reconstructive surgery and 
second-look laparoscopy. 
Adhesion score (on a 0- to 
11-point scale), the area of 
adhesion (cm2), and the 
likelihood of no adhesions. 
The use of both barriers was 
associated with a lower 
adhesion score and area of 
adhesion postoperatively. 
However, those sidewalls 
covered with PTFE had a 
significantly lower adhesion 
score (0.97 +/- 0.30 versus 
4.76 +/- 0.61 points, mean +/- 
SEM) and area of adhesion 
(0.95 +/- 0.35 versus 3.25 +/- 
0.62 cm2). Overall, more 
sidewalls covered with PTFE 
had no adhesions (21 versus 
7) and, when adhesions were 
present on the contralateral 
sidewall, the number of 
sidewalls covered with PTFE 
Expanded 
polytetrafluoroethy
lene was 
associated with 
fewer postsurgical 
adhesions to the 
pelvic sidewall 
than oxidized 
regenerated 
cellulose. 

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without adhesions was greater 
than those covered with 
oxidized regenerated cellulose 
(16 versus 2). 
Franklin 
RR[18] 
In a multicenter randomized 
study, 55 patients with 
bilateral ovarian disease 
were treated at initial 
laparotomy. At the end of the 
procedure, one ovary was 
assigned randomly to be 
wrapped with INTERCEED™  
and the other was left 
uncovered. A second-look 
laparoscopy was performed 
10-98 days later to evaluate 
the occurrence and severity 
of adhesions and the raw 
ovarian surface area exposed 
after lysis of adhesions. 
At second-look laparoscopy, 
26 of 55 INTERCEED™ 
-treated ovaries were free of 
adhesions, compared with 14 
of 55 untreated control ovaries, 
a statistically significant 
difference (P = .028, Fisher 
exact test). At second-look 
laparoscopy, ovaries treated 
with INTERCEED™  formed 
adhesions less extensively 
(1.66 +/- 0.34 cm2) than did 
untreated ovaries (2.75 +/- 
0.60 cm2) and with a greater 
reduction of raw ovarian 
surface area (difference in area 
differential -1.89 +/- 0.96 cm2; 
P = .055, paired t test). 
Adhesion scores at 
second-look laparoscopy were 
reduced significantly for 
ovaries treated with 
INTERCEED™  compared 
with untreated ovaries (P = .02, 
Wilcoxon signed-rank test). No 
adverse events were recorded 
during the course of the study. 
Treatment of 
ovaries with 
INTERCEED™  
significantly 
reduced the 
occurrence and 
severity of 
postsurgical 
ovarian adhesions. 
Nordic 
Adhesion 
Preventi
on Study 
Group[19] 
Prospective, randomized, 
multicenter, controlled clinical 
study was performed. 
Sixty-six women suffering 
from infertility due at least in 
part to bilateral tubal disease 
with bilateral adhesions 
attached to ovaries, fallopian 
tubes, and fimbriae. 
Adhesiolysis bilaterly through 
laparotomy with microsurgical 
techniques, application of 
INTERCEED™  on one of 
the sides randomly assigned 
not known by the surgeon 
before application, follow-up 
When the initial scores 
registered at the operation for 
fertility were compared with 
those registered at the 
second-look laparoscopy, the 
results indicated that gentle 
microsurgical techniques 
resulted in a significant 
reduction of postoperative 
adhesions. Adnexa, which 
were covered with 
INTERCEED™ , had 
significantly lower adhesion 
scores than the control 
adnexa, representing an 
improvement of 39% compared 
In a prospective, 
randomized, 
multicenter, 
controlled clinical 
study using a 
protocol in which 
other adjuvants 
have been shown 
not to be 
efficacious, 
INTERCEED™  
was shown to 
reduce 
significantly the 
incidence and 
severity of 

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laparoscopy 4 to 10 weeks 
postoperatively, with each 
patient serving as her own 
control. Adhesion severity 
scores at all sites and 
number of adhesion free 
organs after laparotomy and 
follow-up laparoscopy.  
with microsurgery alone 
(control) in reducing adhesion 
reformation scores. When 
combined with microsurgical 
techniques, INTERCEED™  
reduced adhesion reformation 
scores by 70%. The number of 
ovaries, fallopian tubes, and 
fimbriae without adhesions at 
the time of second-look 
laparoscopy was significantly 
increased by approximately 
twofold when organs were 
covered with INTERCEED™ . 
adhesion 
reformation to the 
ovary, fallopian 
tube, and fimbria 
after infertility 
surgery. 
Mais V, 
Ajossa S, 
Piras B, 
Guerrier
o S, 
Marongiu 
D, Melis 
GB.[20] 
To evaluate the effectiveness 
of the oxidized regenerated 
cellulose absorbable barrier 
(INTERCEED™ , TC7) in the 
prevention of de-novo 
adhesion formation after 
laparoscopic myomectomy, a 
prospective and randomized 
study was performed at the 
Department of Obstetrics and 
Gynaecology of the 
University of Cagliari, 
Cagliari, Italy. A total of 50 
pre-menopausal 
non-pregnant women, aged 
23-42 years, who submitted 
to laparoscopic myomectomy 
from January 1993 to June 
1994, were randomized to 
surgery alone (control group, 
n = 25) or surgery and 
oxidized regenerated 
cellulose barrier 
(INTERCEED™  group, n = 
25). Neither group received 
any other treatment for 
adhesion prevention. A 
second-look laparoscopy was 
performed 12-14 weeks after 
laparoscopic myomectomy. 
The numbers of adhesion-free 
patients were three out of 25 
(12%) in the control group and 
15 out of 25 (60%) in the 
treatment group (P < 0.05). 
In conclusion, the 
oxidized 
regenerated 
cellulose 
absorbable barrier 
significantly 
reduced de-novo 
adhesion 
formation after 
laparoscopic 
myomectomy. 
Mais V, 
Ajossa S, 
Marongiu 
Thirty-two premenopausal 
nonpregnant women who had 
severe endometriosis and 
Twelve of 16 (75%) women 
treated with the oxidized 
regenerated cellulose barrier 
The oxidized 
regenerated 
cellulose 

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D, 
Peiretti 
RF, 
Guerrier
o S, 
Melis 
GB.[21] 
complete posterior cul-de-sac 
obliteration and were 
undergoing laparoscopic 
surgery were randomly 
assigned to either surgery 
alone or surgery and 
INTERCEED™ . None of the 
subjects received any other 
treatment for adhesion 
prevention. Second-look 
laparoscopy was performed 
12-14 weeks after 
laparoscopic surgery by an 
investigator blinded to the 
treatment, and the incidence 
of adhesion-free subjects 
was assessed. 
were free of adhesions, 
compared with two of 16 
(12.5%) controls, a statistically 
significant difference (P < .05). 
absorbable barrier 
significantly 
reduces adhesion 
reformation after 
laparoscopic 
surgery for 
endometriosis. 
 
As described in the above table, INTERCEED™ has been applied in clinical practice for more 
than 30 years so far. There are a large number of publications showed that it can significantly 
reduce the occurrence of postoperative adhesions. 
 
4.3. Product registration and the reason for clinical trial registration in China 
INTERCEED™ first passed the BSI Design Examination in November 2002 and obtained the EC 
Design-Examination Certificate. The “Design-Examination Certificate” was extended in February 
2015. 
This product has been applied in clinical practice in many countries around the world, including 
many EU, USA, Canada, Latin American countries, Asia-Pacific countries, Middle Eastern and 
African countries. 
This product has not been used in general abdominal operations in Chinese population. Therefore, 
the clinical study is designed to support the registration of the product in China. 
 
5. Features, structural composition, operation principle, mechanism of action 
and study population 
5.1. Features 
5.1.1. Design Features of Study Product 
INTERCEED™ is a sterile, single-use-only, absorbable off-white knitted fabric prepared by the 
controlled oxidation of regenerated cellulose. INTERCEED™ is applied dry in general abdominal 
and gynecological operations, after meticulous hemostasis has been achieved, in order to reduce 
the occurrence of postoperative adhesions. 

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INTERCEED™ reduces the formation of adhesions by physically separating the surfaces of 
tissues that are adjacent to each other during the reperitonealization phase. 
When used as directed, INTERCEED™ is easy to apply and is absorbed from the site of 
implantation within four weeks. Absorption rate depends upon several factors, including the 
amount used and implantation site. 
5.1.2. Material Features of Study Product 
INTERCEED™ is a sterile, single-use-only, absorbable off-white knitted fabric prepared by the 
controlled oxidation of regenerated cellulose. The oxidized regenerated cellulose knitted fabric is 
weaved of 60D and 24-strand lustrous rayon. See Fig. 1 below. 
Fig. 1 Picture of INTERCEED™ 
 
         INTERCEED™        Enlarged view of knitted fabric 
The oxidized regenerated cellulose is a copolymer composed of 68-80 mole percentage of uronic 
acid and 20-32 mole percentage of glucosyl group. The carboxyl group content is 12%-18%. 
The chemical structural formula is as follows. 
 
5.2. Structural Composition, Operation Principle and Mechanism of Action 
5.2.1. The study product is a sterile, single-use-only, absorbable off-white knitted fabric prepared 
by the controlled oxidation of regenerated cellulose. 
5.2.2. The operation principle and mechanism of action of the study product are to reduce the 
formation of adhesions by physically separating the surfaces of tissues that are adjacent 
to each other during the reperitonealization phase. 
5.3. Study Population 

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The study population will include 220 subjects scheduled to undergo laparoscopic radical 
resection of rectal carcinoma with preventive loop ileostomy. 
 
6. INDICATIONS AND CONTRAINDICATIONS, PRECAUTIONS 
6.1. Indications: 
INTERCEED™ is indicated as an adjuvant in general abdominal and gynecological pelvic surgery 
for reducing the incidence, extent and severity of postoperative abdominal adhesions after 
meticulous hemostasis has first been achieved. 
6.2. Contraindications: 
INTERCEED™ is contraindicated in the presence of frank infection.  
INTERCEED™ is not indicated as a hemostatic agent. Appropriate means of achieving 
hemostasis must be employed. 
6.3. Precautions: 
Use only a single layer of INTERCEED™, since multiple layers of packing or folding will not 
enhance the adhesion barrier characteristics and may interfere with the absorption rate of 
INTERCEED™. Care should be exercised in applying INTERCEED™ to a pelvic or abdominal 
organ not to constrict or restrict it. 
Wrapping directly around gastrointestinal anastomoses is not recommended. 
If the product comes in contact with blood prior to completing the procedure, it should be 
discarded, as fibrin deposition cannot be removed by irrigation and may promote adhesion 
formation. 
The safety and effectiveness of using INTERCEED™ in combination with other 
adhesion-prevention treatments have not been clinically established. 
INTERCEED™ is supplied sterile. As the material is not compatible with autoclaving or ethylene 
oxide sterilization, INTERCEED™ must not be resterilized. 
Foreign-body reactions may occur in some patients. 
Interactions may occur between INTERCEED™ and some drugs used at the surgical site. 
Pathologists examining sites of INTERCEED™ placement should be made aware of its usage 
and of the normal cellular response to INTERCEED™ to facilitate proper evaluation of specimens. 
There is no evidence to suggest, or reason to believe, that the use of INTERCEED™ has any 
deleterious effect on the mother or fetus when used during pregnancy or that the product or its 
breakdown products would have an effect on lactation. However, ectopic pregnancies have been 
associated with fertility surgery of the female reproductive tract. No adequate and well-controlled 
studies have been conducted in women who become pregnant within the first month after 
exposure to INTERCEED™. No data exist to establish the effect, if any, of INTERCEED™ on the 
occurrence of ectopic pregnancies. No teratogenic studies have been performed. Therefore, an 
avoidance of conception should be considered during the first complete menstrual cycle after use 
of INTERCEED™. 

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7. OVERALL DESIGN 
7.1. Trial Design 
7.1.1. Trial Objective 
The primary objective of this study is to evaluate the efficacy and safety of INTERCEED™ in 
reducing the incidence of adhesions at the target incision site in patients undergoing 
laparoscopic colorectal surgery. 
7.1.2. Trial Endpoint 
Primary Endpoints 
The primary endpoint is defined as the proportion of subjects with adhesions at the target 
incision site in each study group. 
The assessment of adhesions will be conducted during the second laparoscopy for ileostomy 
reversal. 
The primary endpoint will be assessed by means of reviewing the imaging data by independent 
central reviewers who will be blinded to the study treatment groups. The image data is defined as 
the video which is not shorter than 30 seconds taken through laparoscopy during Phase 2 
operation and allowing an observation of the entire product application site and surrounding areas 
in the treatment group or the target incision site in the control group. 
Secondary Endpoints 
a. 
Extent of adhesions (including severity):  
The extent of adhesions to the incision and abdominal wall between organs will be evaluated 
by the following grading scale[1] respectively: 
Severity 
— Grade 1: filmy thickness, avascular 
— Grade 2: moderate thickness, limited vascularity 
— Grade 3: dense thickness, vascularized 
Extent (percentage of the area covered by adhesion) 
— Grade 1: mild, covering up to 25% of the total area and length 
— Grade 2: moderate, covering 26%–50% of the total area and length 
— Grade 3: severe, covering over 50% of the total area and length 
For quantifying the extent of adhesions to the abdominal wall and between organs, the 
abdominal cavity will be divided into four abdominal quadrants as follows: 

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b. 
Incidence of patients with mechanical ileus: defined as the mechanical ileus judged by 
investigators, which occurred 1 week after Phase 1 operation: 
c. 
Incidence of patients with surgical site infections (SSI) following surgery: according to 
the criteria of the US Centers for Disease Control (CDC) and Prevention of  [22] as follows: 
CDC Definition of SSI 
 
1. 
Superficial incisional SSI: 
Infection occurs within 30 days after the operation and infection involves only skin or 
subcutaneous tissue of the incision and at least one of the following: 
• 
Purulent drainage, with or without laboratory confirmation, from the superficial 
incision; 
• 
Organisms isolated from an 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 superficial incision, is deliberately opened by 
surgeon, unless incision is culture-negative; 
• 
Diagnosis of superficial incisional SSI by the surgeon or attending physician. 
Do not report the following conditions as superficial SSI: 
• 
Stitch abscess (minimal inflammation and discharge confined to the points of suture 
penetration); 
• 
Incisional SSI that extends into the fascial and muscle layers (see deep incisional 
SSI). 
 
2. 
Deep incisional SSI: 

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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 involves deep soft tissues (e.g., fascial and muscle layers) of the incision and at 
least one of the following: 
• 
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℃), 
localized pain, or tenderness, unless site 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.  
Notes: 
• 
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 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 
following: 
• 
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. 
d. 
Incidence of postoperative all layer wound dehiscence of the target incision; 
e. 
Incidence of delayed wound healing of the target incision; 
f. 
Any adverse event; 
g. 
Defects of study product. 
 

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7.1.3. Trial Method Selection and Its Rationale 
The following investigational study method is used per the regulatory requirements of “Guidance 
for Absorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance 
for Industry”. 
This is a prospective, multicenter randomized controlled trial. Its rationale is as follows: 
Randomized: randomization will be used to avoid bias in the assignment of treatment to each 
subject, to increase the likelihood that attributes of the subject are evenly balanced across 
treatment groups, and to enhance the validity of statistical comparisons across treatment groups. 
Controlled: the measures and methods maintain the comparability between groups in other 
factors and conditions except whether the anti-adhesion product is used. 
Prospective: the prospective study may reduce the bias.  
The trial will also estimate the appropriate sample size as needed according to the statistical 
hypotheses, using conservative assumed proportions of primary endpoint failures in the test 
group and control group, and the permissible Type I and II error, ensuring the statistical 
significance of the results. 
7.1.4. Measures to Reduce and Avoid Bias 
The randomization method is used in the study. The subjects are randomly allocated to the test 
group and control group according to the same inclusion and exclusion criteria so that the various 
factors including the unknown confounding factors to be evenly distributed in each group, 
eliminating the confounding effect. The selection bias and confounding bias can be reduced by 
the method of randomized trial. 
Blinding practices for this study will include the following: 
Patients: Patients will be informed of the 1:1 randomization to determine whether the study 
product will be implanted, but will remain blinded for study treatment (INTERCEED™ or Control) 
until they have completed all study follow-up. 
Implanting surgeon: Given the difference between the INTERCEED™ treatment and Control (no 
adhesion barrier), it will not be possible for the surgeon to be blinded to the treatment. Therefore, 
to avoid any bias in the conduct of the surgical procedure, randomization will take place during the 
primary procedure only after colorectal resection and prior to formation of the temporary loop 
ileostomy.  
In addition, the surgeon who performs assessment of adhesions after the second procedure 
(ostomy takedown) will be independent from the surgeons who performed the surgical procedures, 
including the Phase I and Phase 2 operations. 
Medical Records: All medical records (source documents) documenting the adhesion barrier 
application procedure through hospital discharge and all follow-ups will not be blinded, because 
the operation record will not indicate whether the anti-adhesion product is applied. 
Central reviewers: the image data in the Phase 2 operation will be submitted to the site reviewers 
for evaluation to determine the primary endpoints and secondary endpoints, who will remain 
blinded throughout the study. 

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Monitors: Monitors will not be blinded because the detachable labels provided with the product 
identify the product and may be used in the study device accountability records and patient 
research file for the purpose of device accountability and source document validation. 
The study will also collect the data of objective indicators. The study related data will be recorded 
in the original Medical Records as much as possible, and checked in the monitoring process. The 
training for the investigators should be enhanced so as to assure the scientific attitude of 
investigators. The Investigator should communicate further with the subjects to improve the 
subject compliance. This will help to reduce the informational bias. 
The Central Registration System will be used to record all patients with informed consent and 
screening process and results. All reasons for the withdrawal of subjects from study will be 
properly documented. 
7.1.5. Selection of Subjects: 
1) 
Inclusion Criteria 
• 
Subjects ≥ 18 years of age who require laparoscopic colorectal resection with the formation 
of a temporary diverting loop ileostomy and a planned closure of diverting ileostomy within 3 
to 9 months;  
• 
The subjects should be willing to participate in the study, comply with study requirements, 
follow-up schedule, and give written informed consent prior to any study-related procedures; 
• 
The target incision length ≤ 8cm allowing the INTERCEED™ (product length 10.2cm) to 
overlap at least 1cm beyond each pole of the incision; 
• 
The subject is believed to have life expectancy ≥ 12 months after Phase 1 operation, based 
on investigators’ assessment. 
 
2) Exclusion Criteria 
• 
Female patients who are pregnant or lactating at the time of screening; 
• 
Patient with a history of mechanical bowel obstruction, but except the mechanical bowel 
obstruction caused by the colorectal cancer treated in the Phase I operation; 
• 
Subjects with history of mid and lower abdominal region or pelvic surgery; 
• 
Patients for whom it is known that loop ileostomy closure within 3 to 9 months is not feasible 
• 
Patients with a history of active intra-abdominal infection such as peritonitis or abdominal 
abscess; 
• 
Patients with a history of intestinal fistulae; 
• 
Patients with a history of endometriosis; 
• 
Intended use of intraoperative lavage/irrigation with any anti-adhesion solutions other than 
saline (e.g., dextran, heparin, corticosteroids, icodextrin) or an adhesion barrier other than 
INTERCEED™; 

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• 
Use of immune system suppressants deemed by the investigator to interfere with wound 
healing; 
• 
Impaired immune system function or coagulation disorders deemed by the surgeon to 
interfere with wound healing; 
• 
Bevacizumab use within 30 days prior to surgery; 
• 
Subjects with any intra-operative findings identified by the surgeon that may preclude 
conduct of the study procedures; 
• 
Patients with evidence of distant metastasis of the primary colorectal cancer; 
• 
Patients who underwent abdominal radiotherapy before Phase 1 operation; 
• 
Adhesions (Grade 2-3 adhesion[1]) and/or gross contamination (e.g., caused by tumor 
perforation) present in the abdominal cavity at the Phase 1 operation; 
• 
The rectal carcinoma radical resection (R0 resection) + preventive ileostomy are not 
performed in Phase 1 operation; 
• 
Expected resection of other organs (e.g., bladder, uterus, etc.) during Phase 1 operation; 
• 
Use of topical haemostatic products, local chemotherapeutic products or other drugs and/or 
medical device in abdominal/pelvic cavity which may impact the study primary endpoint 
judged by the investigator; 
• 
Patient is participating in other investigational drug or device study within 30 days or 5 
half-lives of an investigational drug;  
• 
A known history of severe multiple drug allergies or known allergy to cellulose or cellulose 
derived products; 
• 
Any medications, treatments and/or implanted devices (except INTERCEED™) that on 
investigator’s opinion may be adhesiogenic or may potentially affect the observation of 
postoperative adhesions; 
• 
Any physical or psychological conditions that at discretion of investigators may impair study 
participation;  
• 
A medical condition or other serious conditions that will interfere with compliance and/or 
ability to complete this study protocol; or 
• 
Any other situation or reason that at discretion of investigators is unsuitable for study 
participation. 
3) Any other situation or reason that at discretion of investigators is unsuitable for 
study participation. Criteria and Procedure of Withdrawal of Subjects from Study 
In accordance with the current revision of the Declaration of Helsinki, a subject has the right to 
withdraw from the study at any time for any reason without prejudice to their future medical care 
by the physician or the institution. Should a subject (or subject’s legally authorized 
guardian/representative) decide to withdraw, 1) all data collected up to the point of withdrawal will 
be considered for analysis; and 2) all efforts will be made to collect and report the final visit 

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observations as thoroughly and timely as possible. The primary reason for early withdrawal will be 
recorded on the electronic case report form (eCRF). The criteria for withdrawal of subjects from 
study including but not limited the following: 
Withdrawal of consent: Any method of contact with the subject in which they state they no longer 
want to participate in the study specific activities constitutes withdrawal of consent for participation 
in the study. This decision must be “self-determination” and should be documented in the 
electronic case report form (eCRF); 
Physician’s determination: the investigator may determine the withdrawal of subjects from study 
according to the reasonable medical judgement; 
Adverse event: the adverse event or serious adverse event 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 adverse event is resolved or until the stable clinical 
endpoint is reached; 
Death: The cause of death will be documented; If the cause of death is related to incisional 
adhesions which is judged by investigators, the subject will not be withdrawn from the study.  
Loss to follow-up: All subjects should be able to participate in all scheduled clinical follow-ups, 
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 for 3 times to ask the 
subject to participate in all scheduled clinical follow-ups. Each attempt to contact should be 
recorded in the source document. If the subject makes no response to all three times of telephone 
contact, the investigator must send a registered mail to the subject. If the subject makes no 
response to the registered mail and makes no further contact, the subject is considered loss to 
follow-up; the eCRF at the end of study must be completed now. 
Termination by the Sponsor, Data Safety Monitoring Board or health authorities; 
Other:  
1. Tumor recurrence or intra-abdominal metastasis of primary rectal cancer within the 
follow-up period; 
2. The subject undergoes a second abdominal operation that doesn’t meet the definition of 
Phase 2 operation (see Section 3.2) within the follow-up period and without the image 
data as described in the Section 7.1.2.. The abdominal operation included but not limited 
to: 
a. Operation for an obstructive ileus or other critical anatomical structure (e.g. vessel, 
nerve) compression; 
b. Other abdominal operations before the scheduled Phase 2 operation; 
c. The Phase 2 operation conducted sooner than 3 months or didn’t conduct within 9 
months after Phase 1 operation; 
3. The subject experienced anastomotic leakage (Class B and C) after Phase 1 operation 
[23]; 
4. The subject recieved postoperative radiotherapy after Phase 1 operation; 

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5. Any intervention that may affect adhesion formation or wound healing at the target 
incision site judged by the investigator. 
Procedure for Subject’s Withdrawal from the Study Treatment: 
The subjects should continue to receive treatments before the completion of 9-month follow-up 
specified in the study protocol. If the subject is withdrawn from the study early, the reasons for 
termination should be documented in the source document and site files, and submitted via the 
electronic case report form (eCRF). 
The subjects 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 are as follows: 
The sponsor has the right to temporarily or early terminate the studies of single site, multiple sites 
or all sites. Reasons may include, but are not limited to: safety issue or ethical issue, inaccurate or 
incomplete data record, non-compliance or dissatisfactory quality or quantity of the recruited 
subjects. 
Flow of Sponsor’s Discontinuation of the Trial: 
If this study is terminated or discontinued early, the sponsor or its representative should inform 
investigator/affiliated unit and regulatory authority of this study having already been terminated or 
discontinued and the reasons for study termination or discontinuation according to the applicable 
supervision requirements. The sponsor or investigator/affiliated unit should also inform EC and 
submit the reasons for termination or discontinuation according to the applicable supervision 
requirements. In addition, all unused study devices and other materials should be returned 
according to the study procedures of sponsor. 
4) 
Enrolment 
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 
No operation 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 about 60 months, including the time that Ethics Committee of 
each institution takes to sign the trial protocol, duration of follow-up, time for data management 
and statistical analysis and time to write the report. 
6) 
Expected duration of participation of each subject 
The duration of each subject’s participation in the study will be around 6-9 months according to 
the follow-up schedule specified in the protocol. 
7) 
Number of subjects required for clinical trial 

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Two hundred and twenty subjects will be included in this study, including 110 for test group and 
110 for control group. See Section 8 “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 endpoint is defined as the proportion of subjects free of adhesions at the target 
incision site in each study group. 
In addition, the secondary parameters will also be collected in this study, including: 
Extent and severity of adhesions; 
Incidence of patients with mechanical ileus. 
2) 
Selection of method and time to evaluate, record and analyze the efficacy parameters 
The primary effective parameter in this study will be assessed by the central reviewers according 
to the image data, which will be collected in the Phase 2 operation, and recorded on the e-CRF. 
The effective data is compared between groups when performing data analysis. 
Extent and severity of adhesions will be assessed by the central reviewers according to the image 
data as described in the Section 7.1.2., which will be collected in the Phase 2 operation, and 
recorded on the e-CRF according to the investigator’s record, the incidence of patients with 
mechanical ileus will be assessed by medical record, investigator report and physical examination, 
which are collected at each follow-up visit after Phase 1 operation. The secondary parameters will 
be compared between groups when performing data analysis. 
7.1.7. Safety Evaluation Method 
1) 
Description of safety parameters 
The safety parameters in this study are the incidence of surgical site infections, wound 
dehiscence, delayed wound healing, any adverse events and defects of study product. 
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 inspection result, which are collected at each follow-up visit. The safety data is 
compared between groups when performing data analysis. 
7.2. Study Process 
 
 
 
7.2.1. Study Flowchart 
The list of time and events of trial is as follows: 
Item 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
Visit 7 h 

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Time point 
Screening/Ba
seline: 
performed 
whthin 14 
days before 
Phase 1 
operation 
Randomizatio
n:performed 
during the 
Phase 1 
operation 
Phase 1 
operation 
Post-Op 
(Phase 1) 
through 
Discharge 
Phase 2 
operation: 
performed 
between 3-9 
months after 
Phase 1 
operation a 
3 days after 
Phase 2 
operation or 
Discharge 
6-7months 
after Phase 1 
operation 
Informed 
consent 
X 
 
 
 
 
 
 
Demographic 
information 
X 
 
 
 
 
 
 
Randomizatio
n 
 
X 
 
 
 
 
 
Inclusion/Excl
usion Criteria 
X 
X 
 
 
 
 
 
Urine/blood 
pregnancy 
test 
X 
 
 
 
 
 
 
Medical/Surgi
cal history b 
X 
 
 
 
X 
 
X 
Concomitant 
therapyc 
X 
 
X 
X 
X 
X 
 
Physical 
examination d 
X 
 
 
X 
X 
X 
 
Concomitant 
medicationse 
X 
 
X 
X 
X 
X 
 
Procedural 
data f 
 
 
X 
 
X 
 
 
Mechanical 
ileus 
 
 
 
X 
X 
X 
X 
SSI 
 
 
 
X 
X 
X 
X 
Incision 
dehiscence 
 
 
 
X 
X 
X 
X 
Delayed 
wound 
healing 
events 
 
 
 
X 
X 
X 
X 
Adverse 
event 
X 
 
X 
X 
X 
X 
X 
Defectts 
of 
study product 
 
 
X 
X 
X 
X 
 
Study 
completion g 
 
 
 
 
 
X 
X 
 
a. 
Other information except operative data should be collected from admission to hospital to the day before operation. 
b. 
The surgical history should be collected carefully in the two visits. 
c. 
The neoadjuvant radiotherapy information should be collected at Screening/Baseline visit, if any. The radiotherapy 
information includes dose and site. 
d. 
Including height, weight and abdominal sign. 
e. 
Only including the medicine related to adverse events and which is used beyond two weeks. The 
neoadjuvant/postoperative chemotherapy protocol and period should also be collected. 
f. 
The information about the procedure time, hemorrhage volume, use of sterile gloves, target incision, application of study 
product in the study group should be collected at the visits of Phase 1 operation; the image data and the treatment for 

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adhesion (if any) should be collected in the Phase 2 operation.  
g. 
If Visit 6 occurs 6-9 months after Phase 1 operation, the study completion would be in Visit 6. If not, the study completion 
would be in Visit 7. 
h. 
Phone contact. If Visit 6 occurs 3-6 months after Phase 1 operation, the Visit 7 need to be conducted. 
7.2.2. Standard Operating Procedures of Medical Device 
According to IFU and technical manual of the product, the requirements for the use of study 
product are as follows: 
a. Indications and scope of application 
INTERCEED™ is indicated as an adjuvant in general abdominal and gynecological pelvic surgery 
for reducing the incidence, extent and severity of postoperative abdominal adhesions after 
meticulous hemostasis has first been achieved. 
 
b. Recommended operating mode 
1) 
To minimize the formation of postoperative adhesions and to optimize the performance of 
the study product, the following surgical techniques, as appropriate, are recommended: 
use of magnification; use of fine-caliber microsurgical instruments; use of fine suture 
material of low tissue reactivity; achievement of meticulous hemostasis; minimization of 
tissue handling; prevention of desiccation of tissues; avoidance of introduction of foreign 
bodies, such as talc, in the operative field; and precise reapproximation of tissue planes; 
2) 
This product should be applied just before closure of the surgical area in order to 
minimize possible dislodging during the remainder of the surgical procedure. 
3) 
Meticulous hemostasis must be achieved before application. 
4) 
Remove all irrigation fluid and instillates from the peritoneal cavity. If Trendelenburg 
positioning was used during the procedure, place patient in reverse Trendelenburg 
position, if possible, to remove as much of the irrigation fluid as possible from the 
cul-de-sac. 
5) 
After obtaining meticulous hemostasis, the following steps are recommended in applying 
the study product. 
a. 
Remove the sheet of study product from the product packaging. 
b. 
Cut pieces of study product to desired size, which should be sufficient to completely 
cover the area at risk. 
c. 
Apply the study product dry, in a single layer. After expanding the omentum majus to 
the greatest extent, lay the study product above the omentum majus and below the 
target surgery incision. Do not fold, wad, or apply multiple layers. Most importantly, 
do not conjoin or coat adjacent structures within one layer as this will hold these 
surfaces together and may potentially promote adhesion formation. Since the study 
product adheres well to serosal tissue, it is not necessary to suture in place. 
Moistening the study product with 1 to 2 ml of irrigating solution after positioning will 
further ensure adherence and conformance of the study product to the application 

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site. If moistening is desirable, this should be done 1) only after the study product is 
placed on the deperitonealized serosal area and 2) caution is exercised to prevent 
the fabric from floating off the surface. If the latter occurs, the piece of the study 
product should be discarded and a new piece used. If the product comes in contact 
with blood prior to use, it should be discarded, as fibrin deposition cannot be 
removed by irrigation and may promote adhesion formation. 
d. 
Hold the study product in place at site of application to ensure adherence. 
e. 
Assess the site after the application of study product for discoloration of the device. 
The study product that is dark brown or black indicates incomplete hemostasis. If 
discoloration occurs, it will occur within 1 to 2 minutes following application of the 
study product. This will render the product ineffective as an adhesion barrier and 
may promote adhesion formation. Should this discoloration occur, remove the study 
product and achieve hemostasis. Apply new piece of the study product as specified 
above. 
c. Warnings and precautions 
Use only a single layer of INTERCEED™, since multiple layers of packing or folding will not 
enhance the adhesion barrier characteristics and may interfere with the absorption rate of 
INTERCEED™. Care should be exercised in applying INTERCEED™ to a pelvic or abdominal 
organ not to constrict or restrict it. 
If the product comes in contact with blood prior to completing the procedure, it should be 
discarded, as fibrin deposition cannot be removed by irrigation and may promote adhesion 
formation. 
The safety and effectiveness of using INTERCEED™ in combination with other 
adhesion-prevention treatments have not been clinically established. 
INTERCEED™ is supplied sterile. As the material is not compatible with autoclaving or ethylene 
oxide sterilization, INTERCEED™ must not be resterilized 
Foreign-body reactions may occur in some patients. 
Interactions may occur between INTERCEED™ and some drugs used at the surgical site. 
Pathologists examining sites of INTERCEED™ placement should be made aware of its usage 
and of the normal cellular response to INTERCEED™ to facilitate proper evaluation of specimens. 
There is no evidence to suggest, or reason to believe, that the use of INTERCEED™ has any 
deleterious effect on the mother or fetus when used during pregnancy or that the product or its 
breakdown products would have an effect on lactation. However, ectopic pregnancies have been 
associated with fertility surgery of the female reproductive tract. No adequate and well-controlled 
studies have been conducted in women who become pregnant within the first month after 
exposure to INTERCEED™. No data exist to establish the effect, if any, of INTERCEED™ on the 
occurrence of ectopic pregnancies. No teratogenic studies have been performed. Therefore, an 
avoidance of conception should be considered during the first complete menstrual cycle after use 
of INTERCEED™. 
7.2.3. Study Procedure 

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Laparoscopic rectal carcinoma radical resection (R0 resection) + preventive terminal 
ileostomy: 
This surgery is the Phase 1 operation in this study. It is suggested that no more than three groups 
of surgeons at each site perform this surgery, including the implantation of study product and the 
wound closure procedure of target incision to minimize bias and variability. The laparoscopic 
rectal carcinoma radical resection (R0 resection) will be performed per each institutional 
requirements or specific guidelines. The target incision should be the mid-line incision and is 
recommended to be about 5-8cm, but not longer than 8cm. The stoma should be on the right side 
of the patient and is recommended to be lateral to the right midclavicular line. The drainage tube 
(if applicable) could be placed on either side of the patient according to the standard of care of the 
participating site and should be at the discretion of the investigator away from the target incision 
as much as possible.  
Implantation of study product and the closure procedure of incision in laparoscopic 
surgery: 
The absorbable suture should be used for all subjects to close target incision (except the skin 
layer). For the patients who are randomized to receive the study product (INTERCEED), the 
physician will implant the study product in the abdominal cavity beneath the target incision. See 
below for the specific implantation method of the study product.  
Application of INTERCEED™ to the target incision site: 
• 
The size of INTERCEED™ should be sufficient to completely cover the target area (the 
incision size ≤ 8cm); 
• 
Apply INTERCEED™ dry, in a single layer; 
• 
It should be placed on denuded/injured surface (target incision site) to mechanically prevent 
this area from adhering to visceral surfaces, thus minimizing resultant adhesion formation; 
• 
Do not fold, plug or apply multiple layers; 
• 
INTERCEED™ adheres well to serosal tissue; it is not necessary to suture in place; 
• 
Hold INTERCEED™ in place at site of application to ensure adherence; 
• 
Moistening the INTERCEED™ with 1- 2 ml of irrigating saline solution (NaCl 0.9%) after 
positioning will further ensure its adherence and conformance to the application site; 
• 
If moistening is desirable, this should be done only with solution (NaCl 0.9%) after 
INTERCEED™ is placed on the de-peritonealized serosal area cautiously keeping the fabric from 
floating off the surface; 
• 
If floating off the surface occurs, the piece of INTERCEED™ should be discarded and a new 
piece used;  
• 
If the product comes in contact with blood prior to use, it should be discarded because fibrin 
deposition on INTERCEED™ (ORC fabric) cannot be removed by irrigation and may promote 
adhesion formation; 
• 
INTERCEED™ will be applied at the target incision to minimize possible dislodging during 
the remainder of the surgical procedure; 

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• 
Discoloration of the device to dark brown or black indicates incomplete hemostasis; 
• 
If such discoloration occurs, it will happen within 1-2 minutes following application of 
INTERCEED™ and will reduce its effectiveness as an adhesion barrier and may promote 
adhesion formation; 
• 
Should this discoloration occur, the device should be removed and complete hemostasis 
achieved before new piece of INTERCEED™ can be applied. 
Postoperative Care: 
Postoperative care will be performed per institutional requirements for clinical practice or specific 
guidelines regarding postoperative care. Patient status is monitored closely until discharge. 
Changes in concomitant medications including analgesics will be recorded throughout inpatient 
stay. 
Neoadjuvant radiation/chemotherapy and postoperative chemotherapy: 
The neoadjuvant radiation/chemotherapy and postoperative chemotherapy will be performed per 
institutional requirements for clinical practice or specific guidelines, except, abdominal 
radiotherapy between primary procedure and ostomy takedown (reversal). Patient status is 
monitored closely until discharge. The scope of neoadjuvant radiation is limited to pelvic cavity. 
Ileostomy reversal + laparoscopic exploration： 
This surgery is the Phase 2 operation in this study. It is suggested that no more than three groups 
of surgeons at each site perform this surgery. During the surgery, the image data of the target 
incision of Phase 2 operation through laparoscopy should be recorded. The image data is defined 
as the videos which is not shorted than 30 seconds taken through laparoscopy 
Screening 
Subjects will be consented prior to any actual 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 and signing the ICD; 
• 
Verification of the eligibility criteria (Section 7.1) by the PI and/or authorized investigators. 
The verification must be conducted by the PI and/or authorized investigators prior to 
randomization. 
Screening Failures 
Screened subjects who are not enrolled will be considered screen failures. For subjects who are 
determined to be screen failures, only the following data will be recorded on the eCRF: 
• 
Informed consent date; 
• 
Demographic information (age, race, gender, and ethnicity); 
• 
Reason for screening failure. 
Randomization 

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Randomization will occur if the patient meets all inclusion criteria and does not meet any 
exclusion criteria. 
Each case will be randomized to one of two groups in a 1:1 ratio. The only difference between the 
groups will be the use of INTERCEED™ or not. The plan is to randomize at least 110 subjects for 
each of the two groups. The randomization will be used in this study so that the patients cannot 
guess the upcoming assigned group. 
The sponsor, will provide each site with computer-generated randomization envelopes, each 
bearing the subject randomization number, and containing the treatment allocation. 
In the event a potential subject fails intra-operative criteria, and is not randomized to the study, the 
unused randomization envelope should be returned to the series, and used for the next subject 
per its original sequence 
Visit 1 – Baseline/Screening Visit 
The following screening activities will occur prior to the study procedure:  
• 
The subject must be given ample time to review and sign the ICD; 
• 
Collection of demographic information (year and month of birth, race, gender, ethnicity, 
etc); 
• 
Review and collection of medical/surgical history; especially the surgical history; 
• 
Review/collection of inclusion/exclusion criteria and determination as to whether the 
subject is eligible for participation; 
• 
Urine/blood pregnancy test; 
• 
Physical Examination, including height, weight and abdominal sign; 
• 
Concomitant therapy: including the dose and site of neoadjuvant radiotherapy; 
• 
Concomitant medications: Only including the which used beyond two weeks. The 
neoadjuvant chemotherapy protocol and period should also be captured. 
• 
Adverse Events; 
 
Visit 2 – Randomization 
The following must be obtained in this visit: 
• 
Radomization: whether the patients recieved neoadjuvant radiotherapy will be the factor 
of the stratified randomization. 
• 
Confirm inclusion and exclusion criteria 
 
Visit 3 – Phase 1 Operation 
The following must be obtained prior to the surgical procedure: 

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• 
Update to medical/surgical history 
• 
Device usage data: The code and quantity of the used study product, placement position 
and placement method of the study product; 
• 
Procedure time: the time beginning with the opening of the first incision to the closure of 
the last incision. 
• 
Blood loss 
• 
During this operation, adhesions assessment (extent and severity) and any treatment of 
adhesions will be recorded 
• 
Quantity of surgical gloves used: including the surgical sterile gloves used by the doctors 
and instrument nurses; 
• 
Length and closure method of the target incision: the sutures and closure method also 
should be recorded.  
• 
Intra-operative device failure; 
• 
Concomitant medications: Only including the medicine related to adverse events and 
which used beyond two weeks.; 
• 
Concomitant therapy; 
• 
Adverse Events; 
• 
Defects of study product. 
 
Visit 4 – Post-Op through Discharge 
The following must be obtained in this visit: 
• 
Concomitant medications: Only including the medicine related to adverse events and 
which used beyond two weeks. The postoperative chemotherapy protocol and period 
should also be captured (if any); 
• 
Concomitant therapy; 
• 
Adverse Events (Concomitant medication associated with AEs will also be collected); 
• 
Defects of study product; 
• 
Mechanical ileus; 
• 
Physical Examination, including abdominal sign. 
• 
SSI; 
• 
All layer Wound dehiscence; 
• 
Delayed wound healing events;. 
 

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Visit 5 – Phase 2 Operation 
The following information must be obtained in this visit: 
• 
Review and collection of medical/surgical history: the sugical history should be collected 
carefully;  
• 
Concomitant therapy; 
• 
Physical Examination including abdominal sign; 
• 
Concomitant medications: Only including the medicine related to adverse events and 
which used beyond two weeks. The postoperative chemotherapy protocol and period 
should also be captured (if any); 
• 
SSI; 
• 
All layer Wound dehiscence; 
• 
Delayed wound healing events; 
• 
Adverse Events (Concomitant medication associated with AEs will also be collected); 
• 
Defects of study product; 
• 
Mechanical ileus; 
• 
Operative data: the image data of operation needs to be recorded as follow: starting from 
the upper left quadrant and proceeding clockwise to the lower left quadrant. If the 
incisional adhesion was found, whether and how the treatment for the adhesion 
performed should be recorded. 
 
Visit 6 – Post-Op through Discharge 
The following must be obtained in this visit: 
• 
Concomitant medications: Only including the medicine related to adverse events and 
which used beyond two weeks; 
• 
Concomitant therapy; 
• 
Adverse Events; 
• 
Defects of study product; 
• 
Mechanical ileus; 
• 
Physical Examination including abdominal sign. 
• 
SSI; 
• 
All layer Wound dehiscence; 
• 
Delayed wound healing events; 

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• 
Study completion: If this visit occurs 6-9months after Phase 1 operation, study 
completion would be conducted in this visit. 
 
Visit 7 – 6-7 months after Phase 1 operation (Phone contact) 
If Visit 6 occurs 3-6 months after Phase 1 operation, this visit should be conducted. The following 
must be obtained in this visit: 
• 
Review and collection of medical/surgical history: the sugical history and the diagonosis 
which may related to abdominal adhesions should be collected carefully; 
• 
Adverse Events; 
• 
Defects of study product; 
• 
Mechanical ileus; 
• 
SSI; 
• 
All layer Wound dehiscence; 
• 
Delayed wound healing events; 
• 
Study completion. 
 
7.3. Monitoring Plan 
This study is performed according to the Good Clinical Practice for Medical Device Trials and 
related international laws and regulations, criteria, etc., such as ISO 14155, the Declaration of 
Helsinki. 
The sponsor bears the monitoring responsibility for the clinical trial and will select the qualified 
monitor to execute the monitoring responsibility. 
The monitor should comply with the related laws and regulations and the standard operating 
procedure established by the sponsor with regard to the monitoring to monitor each phase of this 
study. 
The monitor should contact and visit the investigators at a regular basis and make the field 
visit/monitoring for the study. The monitor should make a visit when the first subject is enrolled, 
and make a necessary visit at a regular basis (about every 4 or 6 weeks) during the study period. 
The monitoring includes the visit to clinical trial institution, verification of CRF data, 
communication with investigators and clinical trial institution, ensuring that this study will be 
performed strictly in compliance with the trial protocol and the requirements of regulations of Good 
Clinical Practice, etc. 
The on-site inspection of CRF includes verifying the source document and checking whether 
original data is true, accurate, complete and clear, the original document of each subject is 
complete. 
This study may be subject to the audit by the sponsor or regulatory authority. If such audit is 

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performed, the investigator 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 attached monitoring plan for the detailed monitoring plan. 
8. STATISTICAL CONSIDERATIONS 
8.1. Statistical Design, Method and Analysis Procedure 
This study is a prospective, multicenter, randomized controlled study to evaluate the superiority of 
INTERCEED™ compared to blank control in reducing the incidence of postoperative incision 
adhesions in laparaoscopic surgery. 
The primary effectiveness endpoint is the proportion of subjects free of abdominal incision 
adhesions at primary target incision site observed in the two treatment groups (INTERCEED™ 
and Control). The assessment of adhesions will be conducted during the second laparoscopy for 
ileostomy reversal. 
The statistical hypotheses for the primary endpoint are as follows: 
• 
H0: PI ≤ PC tested against the alternative hypothesis 
• 
Ha: PI > PC 
where PI is the proportion of subjects free of adhesions in the INTERCEED™  group and PC is 
the proportion of subjects with adhesions in the Control group. 
The proportion of subjects free of adhesions will be summarized for each treatment group and will 
be calculated as the number of subjects free of adhesions divided by the total number of subjects 
randomized to that treatment. Within-treatment group two-sided 95% confidence intervals for the 
proportions of subjects free of adhesions will be provided using Clopper-Pearson method. In 
addition, a one-sided Wald 97.5% confidence interval for the difference in two independent 
proportions (INTERCEED™ minus Control) will be constructed and used for testing the null 
hypothesis of superiority stated above. If the lower limit of the confidence interval is greater than 0, 
then it will be concluded that INTERCEED™ is superior to Control. 
The primary endpoint will be analyzed using the Intent-to-Treat (ITT) and Per-Protocol (PP) sets. 
The ITT analysis will be considered primary, while the PP analysis will be considered supportive. 
The analysis sets for this study are defined in section 8.9. 
The following secondary effectiveness endpoints will be summarized descriptively by treatment 
group for the ITT analysis set: 
• 
Extent and severity of adhesions--at the incision site and four abdominal quadrants; 
• 
Incidence of subjects with mechanical ileus. 
In addition, the following safety endpoints will be summarized descriptively by treatment group for 
the Safety analysis set: 
• 
Incidence of subjects with surgical site infections (SSI) of target incision after Phase 1 
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• 
Incidence of postoperative all layer wound dehiscence of target incision after Phase 1 
operation; 
• 
Incidence of subjects with delayed wound healing events of target incision after Phase 1 
operation; 
• 
Any adverse event; 
• 
Defects of study product. 
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. 
All analyses/summaries will be produced using SAS (Version 9.1 (EG) or later). 
 
8.2. Calculation of Sample Size 
8.2.1. Total Sample Size: 220 patients. 
The relevant literature review revealed observed percentages of subjects with pelvic wall 
adhesions of 41% and 49.3% for INTERCEED™ and of 76% for Control[12,13]. As a 
consequence, for the sample size determination, the assumption was conservatively made that 
the proportions of subjects with adhesions in INTERCEED™ and Control groups would be 0.5 
and 0.75, respectively. With a one-sided significance level of 0.025, a sample size of 77 subjects 
in INTERCEED™ group and 77 subjects in Control group are required to achieve 90% power to 
detect a difference of 0.25 between the two group proportions using a one-sided Chi-square test. 
In order to adjust for a 30% dropout rate, a total of 110 subjects in INTERCEED™ group and 110 
subjects in Control group, for a total of 220 subjects, will be enrolled. 
8.2.2. Minimum and Maximum Number of Subjects in Each Clinical Trial Institution and 
Reasons for determination 
A total of 220 Chinese patients undergoing rectal cancer surgery and needing second stage 
reposition of preventive terminal ileostomy will be enrolled in 12 study sites in China.   
8.3. Significance Level and Power of Clinical Trial 
The power of the statistical test at which the sample size for the primary effectiveness endpoint 
was calculated is 90%, and the significance level of the test was set to 0.025 (one-sided). 
Within-treatment group two-sided 95% confidence intervals for the proportions of subjects with 
adhesions will be provided using Clopper-Pearson method.  In addition, a one-sided Wald 97.5% 
confidence interval for the difference in two independent proportions (INTERCEED™ minus 
Control) will be constructed and used for testing the null hypothesis of superiority stated in section 
8.1.  If the upper limit of the confidence interval is smaller than 0, then it will be concluded that 
INTERCEED™ is superior to Control. 
8.4. Expected Drop-out Rate 
The expected dropout rate in this study is 30%. 

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8.5. Criterion of Acceptability/Unacceptability of Clinical Trial Result 
For the primary efficacy endpoint, a one-sided Wald 97.5% confidence interval for the difference 
in proportions of subjects with adhesions (INTERCEED™ minus Control) will be constructed and 
used for testing the null hypothesis of superiority stated in section 8.1. If the upper limit of the 
confidence interval is smaller than 0, then it will be concluded that INTERCEED™ is superior to 
Control. 
8.6. Criteria and Reason for Terminating the Trial based on the Statistical Results 
An ad-hoc interim analysis is proposed based on feedback received from the investigators who 
observed very low rate of adhesions at the second procedure for ostomy reversal. 
The conditional power (CP) is the probability that the final result will be significant, given the data 
obtained up to the time of interim look. The table as below shows the CP per different adhesion 
rate difference of INTERCEED vs Control arms at the interim look. 
Given the assumed 30% drop-out rate, it was planned that a total of 154 participants (77 per arm) 
with evaluable primary endpoint are available by the study completion. The interim analysis will be 
performed while at least 94 participants (at least 61% of the total number) have their primary 
endpoints evaluated in the electronic data collection system. If the CP is ≤ 60%, the observed 
adhesion rate difference magnitude between two arms is only around 0.10, which is much less 
than the assumed difference magnitude of 0.25 used for sample size calculation. Therefore, the 
study will be terminated due to low adhesion rate and small effect size between INTERCEED and 
control arms. Otherwise, the study will continue until the study completion as planned. 
There is a database lock for this interim analysis. All data for the analysis will be cleaned with 
100% source data validation. The statistical analysis will be conducted per updated and approved 
protocol and SAP to determine if the interim results meet the pre-specified threshold of early 
discontinuation (CP≤ 60%). 
Table: Conditional power per different treatment effect size observed at interim look 
Observed 
adhesion 
difference between 
INCTERCEED vs 
control at interim 
look 
Data availability at interim look  
Percentage of participants with evaluable primary endpoint (number of participants) 
61% (94) 
66% (102) 
70% (108) 
72% (112) 
75% (116) 
-0.02 
0.19 
0.11 
0.07 
0.04 
0.02 
-0.06 
0.35 
0.26 
0.2 
0.16 
0.12 
-0.08 
0.45 
0.37 
0.3 
0.26 
0.21 
-0.1 
0.55 
0.48 
0.42 
0.38 
0.34 
-0.11 
0.59 
0.54 
0.49 
0.45 
0.41 
-0.12 
0.64 
0.6 
0.56 
0.52 
0.49 
-0.13 
0.69 
0.65 
0.62 
0.6 
0.57 
-0.14 
0.73 
0.7 
0.68 
0.66 
0.64 
-0.15 
0.77 
0.75 
0.74 
0.72 
0.71 

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-0.16 
0.81 
0.8 
0.79 
0.78 
0.78 
-0.18 
0.87 
0.87 
0.87 
0.87 
0.87 
 
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. Reporting Procedure of Deviation from Original Statistical Plan 
Any changes from the original planned statistical analyses will be specified in the protocol 
revisions, if applicable, and/or in a final or amended statistical analysis plan.  
The statistical analysis plan will be updated accordingly per the ad-hoc interim analysis.  
8.9. 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. 
The following three analysis sets are defined in this study: 
• 
The Intent-to-Treat (ITT) set will contain all randomized subjects. 
• 
The Per-Protocol (PP) set will contain all subjects in the ITT set who have no major 
protocol deviations. 
• 
The Safety set will contain all subjects who receive study device. 
Major protocol deviations are deviations that have an impact on the primary endpoint, or that have 
an impact on the randomization assignment. These will be determined prior to database lock.  
The primary effectiveness endpoint will be analyzed using the ITT and the PP set. However, the 
primary analysis will be based on the ITT set.  The PP analysis will be considered supportive. 
In all cases, treatment allocation will be based on randomization for the primary effectiveness 
endpoint using the ITT. If more than 11 subjects are mis-randomized, then an additional 
confirmatory analysis based on treatment received will be performed for the primary effectiveness 
endpoint, using the ITT. 
The secondary effectiveness endpoint will be analyzed using the ITT set, while the safety 
endpoints will be analyzed using the Safety set. 
 
9. Data management 
The individual subject data collected during the period of this trial will be recorded in the 
corresponding database. The data is audited by the data management group after collecting the 
data. Any unexpected or missing data points will generate inquiry and the unexpected or missing 
data will be forwarded to the site for solving it. When all subjects have the opportunity to complete 

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all follow-up evaluation, this study will be closed and the data analysis will be performed. 
10. FEASIBILITY ANALYSIS 
10.1. Likelihood Analysis of Success 
INTERCEED™ was first marketed in America in 1989, which was used in gynecological pelvic 
surgery to prevent the occurrence of postoperative adhesion. It was approved in Europe in 2002 
to be used in abdominal operation. It was introduced in the Chinese market in 2004 and approved 
to be used in gynecological pelvic surgery. It has been widely used at home and abroad for nearly 
30 years. 
INTERCEED™ is a sterile, single-use-only, absorbable off-white knitted fabric prepared by the 
controlled oxidation of regenerated cellulose. INTERCEED™ reduces the formation of adhesions 
by physically separating the surfaces of tissues that are adjacent to each other during the 
reperitonealization phase. 
The currently existing clinical literatures regarding the study product showed that INTERCEED™ 
could reduce the occurrence of postoperative adhesion when compared to the blank control 
[6,7,11-19]. Especially the two papers (e.g. Sekiba and Azziz) [13,14] studying the tissue, pelvic wall 
similar to abdominal wall clearly pointed out that the incidence of adhesions in pelvic wall was 
about 76% when INTERCEED™ was not used, while the incidence of adhesions was reduced to 
40%-50% when INTERCEED™ was used. It can be seen that INTERCEED™ has a prominent 
impact on preventing the occurrence of adhesions [11,12]. 
10.2. Likelihood Analysis of Failure 
Although a large amount of clinical literature showed that INTERCEED™ could reduce the 
occurrence of postoperative adhesion when compared to the blank control, most of these studies 
were limited to uterus and ovary, no clinical literatures related to the application in abdominal 
cavity or abdominal wall.  
An ad-hoc interim analysis is proposed based on feedback received from the investigators who 
observed very low rate of adhesions at the second procedure for ostomy reversal. The ad-hoc 
interim analysis is planned to reevaluate the study assumptions used for hypothesis testing. If the 
assumptions don’t hold, the likelihood analysis of failure may increase to be moderate. 
11. QUALITY CONTROL OF CLINICAL TRIAL 
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 in order to ensure the quality of clinical trial.  
The sponsor should organize the training on clinical trial protocol and the use and maintenance of 
investigational medical device for all investigators participating in the trial, so as 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 
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 

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established by the sponsor to monitor the clinical trial, so as to ensure the complete, accurate, 
true and reliable data. 
To ensure the quality of study, the sponsor may authorize the eligible QA auditor to audit the 
clinical trial as needed. The investigator should allow the auditors to look up the original data and 
documents related to this study after receiving the notification. 
When the food and drug regulatory authority, competent department of health and family planning 
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 
In the whole study process, the study protocol (and update), informed consent form (and update) 
and other applicable documents related to the study must be submitted to the relevant Ethics 
Committee and can’t be implemented until the written approval is obtained. 
Before the subjects participate in the clinical trial, the investigator must fully explain this study and 
answer all questions raised by subjects. Each subject (or legally authorized representative) must 
voluntarily sign and date the informed consent form (and other documents as per local regulations) 
that is approved by the Ethics Committee prior to implementing any study-related operations. The 
process of obtaining the informed consent needs to be clearly documented in the original record 
of the subject. The subject may request to withdraw the informed consent at any time in the study 
process. This withdrawal will not affect the subsequent therapy of the investigator for the subject. 
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 specifications and related standard operating procedure; 
the investigational product should be used according to the approved protocol and related 
operation instructions.  
The collection, use and disclosure of all personal data (including the patient health and medical 
information) should comply with the applicable laws and regulations with regard to the personal 
data protection and security. When collecting and processing such personal data, appropriate 
measures are to be taken to maintain the confidentiality of patient health and medical information 
and to prevent access by unauthorized persons. 
12.2. Approval of Trial Protocol 
The trial protocol should be internally approved and filed according to the company’s standard 
operating procedure (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 

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The informed consent of all potential subjects must be obtained prior to performing any study 
operations/procedures. Once the investigator determines that the patients are suitable for 
participating in this study, the investigator must explain the background of the study presented 
and the benefits and risks of surgery and study to the patients and answer the questions raised by 
patients. Only the patient who signs the informed consent form that is approved by the Ethics 
Committee (EC) prior to participating in the study is eligible to participate in this study. The patient 
who doesn’t sign the written informed consent form is not eligible to participate in this study.  
Each subject (or legally authorized representative) must sign and date the informed consent form 
that is approved by the (EC) (and other documents as per local regulations) 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. The process of obtaining the informed consent must be clearly 
documented by the investigator and/or designated person in the original clinical trial documents of 
subjects. 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.  
12.3.2. Text of Informed Consent Form 
See the Informed Consent Form attached to the protocol. 
13. REGULATIONS OF ADVERSE EVENT AND DEVICE DEFECT REPORTING 
13.1. Adverse event 
An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of 
its relationship to the investigational medical device. 
The investigator should determine whether an AE occurs and determine its relationship to the 
study device or surgery at each evaluation for the subjects recruited for the clinical study. 
All AEs, study device faults and other product problems must be recorded in the medical record 
and entered in the CRF. All AEs need to be recorded in the EDC system in 2 weeks. 
Postoperative pain, fever and laboratory abnormalities is expected and will not be documented as 
an adverse event unless the Investigator considers the pain or fever to exceed that normally 
anticipated following the surgery or related to study devices. Also, the adverse event, not 
including the serious adverse event and ileus event, which is “not relative” or “unlikely related” to 
the study device and occurred 1. between 30 days after Phase 1 operation and the hospitalization 
for Phase 2 operation or 2. between Visit 6 and Visit 7 should not be documented. 
The severity of adverse event is graded into the following levels: 
Mild: Existing signs or symptoms have no impact on the usual activities of the subjects, or 
transient, no treatment required, with no sequel. 
Moderate: Have an impact on the usual activities of the subjects, with no interference, with 
possible need of treatment. 

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Severe: Cause the symptom of severe discomfort, resulting in major impact on the usual activities 
of the subjects, medical intervention or treatment required. 
The causal relationship of adverse events should be determined as follows: 
Not related: The event is definitely not related to the use of product 
Unlikely related: The time sequence between the use of product and the event shows that the 
event is unlikely associated, 
Possibly related: The time sequence between the use of product and the event shows that the 
event is likely associated, or AE may also be caused by the disease or concomitant treatment of 
the subjects, 
Probably related: The time sequence shows the event has temporal relationship to the use of 
investigational product, or the event is alleviated at the end of use of product, or it is unable to give 
reasonable explanation to this event according to the disease of the patient,  
Definitely related: The time sequence shows the event has temporal relationship to the use of 
investigational product, or the event is alleviated after the withdrawal of product, or the event 
occurs again when the product is reused (reactivated). 
13.2. Serious Adverse Event 
A Serious Adverse Event is any AE that results in a death or a serious deterioration in the health 
of the subject during the clinical trial, including a life-threatening illness or injury, a permanent 
impairment of a body structure or a body function, in-patient hospitalization or prolongation of 
existing hospitalization, medical or surgical intervention to prevent permanent impairment of a 
body structure or a body function; or results in fetal distress, fetal death or congenital abnormality, 
congenital anomaly, etc. The rehospitalization events after Phase 1 operation only for receiving 
the chemotherapy/radiotherapy which planned after the diagnosis of the primary disease will not 
be documented as an adverse event. 
13.3. Device Defect 
The device defect is defined as unreasonable risk occurred under normal use of medical device 
during the clinical trial, which may do harm to the human health and life safety, such as label error, 
quality problem, fault, etc. 
For the device defect that may cause serious adverse event, the sponsor should report to the 
CFDA and the competent department of health and family planning at the same level where the 
device is registered within 5 workdays after being informed. The sponsor should also inform other 
clinical trial institutions and investigators that participate the trial, and timely inform the Ethics 
Committee of such clinical trial institution through its administrative department for clinical trial of 
medical device. The investigator should record all adverse events required in protocol and device 
defects found in the process of clinical trial, work with the sponsor to analyze the causes of the 
events, form 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. 
13.4. Reporting Procedure, Contact Information 
The investigator should ensure to provide the sufficient treatment for Any adverse event of any 

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subjects, including the laboratory detection value with clinical significance and related to this 
study. 
The adverse event is reported from the start of signing the informed consent to the end of the 
study of subjects. All adverse events should be followed up, until the adverse event is resolved, 
stable or the study is completed. 
The investigator should record the nature, severity, treatment and outcome of serious adverse 
event, and determine whether it is related to the study device, drug administration or surgery 
specified in the study protocol. The investigator will report the adverse event to the sponsor via 
the Case Report Form (CRF). 
The investigator must submit the serious adverse events occurred in the study and the device 
defects that may cause serious adverse event to the sponsor and the regulatory authorities at 
every level (or designated person) immediately after being informed of the event; if required by 
the sponsor, the further information should be provided. 
All serious adverse events need to be followed up until the event is 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 and sponsor should report the serious adverse events occurred in the study and 
the device defects that may cause serious adverse event to the regulatory authorities at every 
level according to the requirements of laws and regulations. 
The study device with device defect should be returned to the sponsor according to the 
instructions given in Section 13.3 of this study. Once a device defect is found, the site should 
inform the sponsor as soon as possible, and report the device related information on the relevant 
CRF. 
The contact person to report adverse event and device defect is as follows: 
Adverse event: RA-JNJSG-InterceedCN@ITS.JNJ.com  
Device defect: JJMC-productcomplaint-Ethicon@its.jnj.com 
14. 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. The records 
include the date of and reason for protocol deviations. The investigator should also report the 
protocol deviations to the EC according to the procedures and in combination with the 
requirements and procedures of the EC.  
If protocol amendment occurs, the sponsor or designated person should submit the change data 
of 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 
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If an amendment likely has major impact on the following items, this amendment belongs to the 
major amendment: 
 
Safety or physical or mental health of subjects; 
 
Scientific value of trial; 
 
Implementation or management of trial; 
 
Quality or safety of investigational medical device specified in the trial. 
15. DIRECT ACCESS TO SOURCE DATA AND DOCUMENT 
The source data is defined as all information in the original record and its approved copy with 
regard to 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 look up, at least 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; 
 
Process of informed consent; 
 
Operational description of use and implantation of the study product; 
 
All inspection results and follow-ups; 
 
Examined printed output file or report (for example, X-ray film) that is dated and signed; 
 
Image data of Phase 2 operation; 
 
Description of adverse event and follow-ups of adverse event (description of event, severity, 
date of occurrence, duration, correlation with the study device, study procedure, outcome and 
treatment of adverse event, concomitant medications when an adverse event occurs); 
 
Description of device defect; 
 
Study subject’s status at the end of the study or withdrawn from the study. 
The sponsor expects that the appropriate study coordinator and/or investigator, appropriate 
source documents and appropriate environment are available for reviewing the study related 
documents during the period of monitoring and visit. 
16. FINANCES AND INSURANCE 
See the relevant study contract and insurance document. 
17. CONTENTS THAT THE CLINICAL TRIAL REPORT SHOULD COVER 
According to the regulatory requirements, the clinical trial report should be consistent with the 
clinical trial protocol, mainly including: 
.1. 
General information; 

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.2. 
Synopsis; 
.3. 
Introduction; 
.4. 
Clinical trial objective; 
.5. 
Clinical trial method; 
.6. 
Clinical trial contents; 
.7. 
General clinical data; 
.8. 
Investigational medical device and control device or control diagnosis and treatment 
method; 
.9. 
Statistical analysis method and evaluation method used; 
.10. Clinical evaluation criteria; 
.11. Organizational structure of clinical trial; 
.12. Ethical description; 
.13. Clinical trial results; 
.14. Adverse events found in the clinical trial and their treatment; 
.15. Analysis and discussion of clinical trial results, especially the indications, scope of 
application, contraindications and precautions; 
.16. Conclusion of clinical trial; 
.17. Existing problems and improvement suggestion; 
.18. List of investigators; 
.19. Other conditions that need to be described. 
.20. For multicenter clinical trial, it also includes the summary of clinical trial of each sub-site 
18. CONFIDENTIALITY 
The personal data of the subject partipicating in the trial is confidential; however, the Ethics 
Committee, food and drug administration, competent department of health and family planning or 
the sponsor and its authorized representative may look up the personal data of the subject 
partipicating in the trial for the demand of work according to the established procedure. 
The personal data of the subject should be kept confidential during the entire period of clinical trial, 
and it should be ensured that the source data can be verified through the supporting information. 
So, a unique ID number of the subject (site number and subject number) is used to identify all 
data of each subject reported. If the data is kept strictly confidential and it is ensured that the 
privacy of the subject has been protected, the data related to this study is available for the third 
party (for example, under the audit of regulatory authority). 
19. AGREEMENT ON THE PUBLICATION OF TRIAL RESULTS 
If needed, a article for multicenter trial will be prepared and published in the prestigious scientific 

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journal at the end of the study. No major results of experience of any individual site in this study 
are allowed to be published before the multicenter trial results are prepared and published. The 
exception from this regulation needs an prior approval from the sponsor. Other endpoints analysis 
specified preoperatively and non-preoperatively will be implemented in the data management 
department. Such secondary analysis and other proposed investigations need to be approved by 
the sponsor. To timely extract the statement and publish, the second publication will be entrusted 
to the corresponding principal authors. The final anlaysis and review of all multicenter trial data 
are requried to be approved by the sponsor. 
20. RESPONSIBILITIES THAT EACH PARTY SHOULD BEAR 
20.1. Responsibilities of the sponsor 
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’s 
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 instituion and investigators. 
4) 
The sponsor should sign a written agreement with the clinical trial institution and the 
investigator with regard to 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 device in the 
clinical trial. The adverse event, serious adverse event and the device defect that may cause 
serious adverse event 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 should perform the study strictly in compliance 
with the clinical trial protocol, timely correct the protocol deviations and reserve the rights to 
report to the regulatory authority. 
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 instituion and medical staff in the diagnosis and treatment. 
9) 
The sponsor should select the qualified monitor for monitoring and organize the inspection 
appropriately. 
20.2. Responsibilities of Clinical Trial Institution and Investigator 
1) 
The clinical trial institution should evaluate the relevant recources according to the features of 
investigational medical device prior to the clinical trial, so as to decide whether to perform this 
clinical trial. 
2) 
The clinical trial institution should properly keep the records and documents of clinical trial 
according to the agreement with the sponsor. 

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3) 
Make sure that the investigators responsible for the clinical trial should have the qualifiication 
in accordance with the requirements of related laws and regulations.  
4) 
The administrative department for clinical trial of medical device 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. 
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 device 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 adverse event occuring 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 adverse events occurring and device defects found in the 
process of clinical trial, work with the sponsor to analyze the causes of the events, form 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 make sure 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 true, accurate, clear and safe. 
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 of, 
and it should be ensured that the subjects to receive the proper care and follow-up. The 
clinical trial institution and investigator should also report in accordance with the regulations, 
provide the detailed written explanation.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 ensure to complete all records and reports at the end of clinical trial. 

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The investigator should also ensure that the received investigational medical devices are 
properly handled and recorded according to the requirements. 
20.3. Responsibilities of other interested parties  
See the study-related contract 

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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 case report form (CRF) and complete 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 receiving and use condition 
during the clinical trial, and keep record. 
4. Allow the CRA 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) 
Date: DD/MM/YYYY 
 
Comments of investigator 
Signature 
Date: DD/MM/YYYY 
 
Comments of clinical trial institution of medical device 
 
Signature (Stamp) 
Date: DD/MM/YYYY 
 

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APPENDIX 1:  
REFERENCES 
1. Kusunoki M, Ikeuchi H, Yanagi H, Noda M, Tonouchi H, Mohri Y, et al. Bioresorbable 
hyaluronate-carboxymethylcellulose membrane (Seprafilm) in surgery for rectal carcinoma: a 
prospective randomized clinical trial. Surg Today. 2005;35(11):940-5. 
2. Ellis H, Moran BJ, Thompson JN, Parker MC,Wilson MS, Menzies D, et al. Adhesion-related 
hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet 
1999; 353:1476–80. 
3. Trimbos-Kemper TCM, Trimbos JB, van Hall EV. Adhesion formation in tubal surgery: results of 
the eight day laparoscopy in 188 patients. Fertil Steril 1985; 43:395–400. 
4. Bronson RA, Wallace EE. Lysis of periadnexal adhesions for correction of infertility. Fertil Steril 
1977; 28:613–9. 
5. Ray NF, Denton WG, Thamer M, Henderson SC, Perry S. Abdominal adhesiolysis: inpatient care 
and expenditures in the United States in 1994. J Am Coll Surg. 1998 Jan;186(1):1-9. 
6. Matthews BD, Pratt BL, Backus CL, Kercher KW, Heniford BT. Comparison of adhesion formation 
to intra-abdominal mesh after laparoscopic adhesiolysis in the New Zealand White rabbit. Am Surg. 
2002 Nov;68(11):936-40; discussion 941. 
7. Menzies D, Ellis H. Intestinal obstruction from adhesions--how big is the problem? Ann R Coll Surg 
Engl. 1990 Jan;72(1):60-3. 
8. Tinelli A, Malvasi A, Guido M, Tsin DA, Hudelist G, Hurst B, et al. Adhesion formation after 
intracapsular myomectomy with or without adhesion barrier. Fertil Steril. 2011 Apr;95(5):1780-5. 
9. Chapa H O, Venegas G. Maternal morbidity at first repeat cesarean: a sub-analysis of 
INTERCEED barrier placed at primary cesarean section. Open Access Surgery, 2013, 
2013(default):7-12. 
10. Vrijland WW, Tseng LN, Eijkman HJ, Hop WC, Jakimowicz JJ, Leguit P, et al.. Fewer 
intraperitoneal adhesions with use of hyaluronic acid-carboxymethylcellulose membrane: a 
randomized clinical trial. Ann Surg. 2002 Feb;235(2):193-9. 
11. Kusunoki M, Ikeuchi H, Yanagi H, Noda M, Tonouchi H, Mohri Y, et al. Bioresorbable 
hyaluronate-carboxymethylcellulose membrane (Seprafilm) in surgery for rectal carcinoma: a 
prospective randomized clinical trial. Surg Today. 2005;35(11):940-5. 
12. Salum M, Wexner SD, Nogueras JJ, Weiss E, Koruda M, Behrens K, et al. Does sodium 
hyaluronate- and carboxymethylcellulose-based bioresorbable membrane (Seprafilm) decrease 
operative time for loop ileostomy closure? Tech Coloproctol. 2006 Oct;10(3):187-90; discussion 
190-1. 
13. Sekiba K. Use of INTERCEED (TC7) absorbable adhesion barrier to reduce postoperative 
adhesion reformation in infertility and endometriosis surgery. The Obstetrics and Gynecology 
Adhesion Prevention Committee. Obstet Gynecol. 1992 Apr;79(4):518-22. 
14. Azziz R. Microsurgery alone or with INTERCEED Absorbable Adhesion Barrier for pelvic sidewall 
adhesion re-formation. The INTERCEED (TC7) Adhesion Barrier Study Group II. Surg Gynecol 
Obstet. 1993 Aug;177(2):135-9. 

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15. Li TC, Cooke ID. The value of an absorbable adhesion barrier, INTERCEED, in the prevention of 
adhesion reformation following microsurgical adhesiolysis. Br J Obstet Gynaecol. 1994 
Apr;101(4):335-9. 
16. Chapa HO, Venegas G, Vanduyne CP, Antonetti AG, Sandate JP, Silver L. Peritoneal adhesion 
prevention at cesarean section: an analysis of the effectiveness of an absorbable adhesion barrier. 
J Reprod Med. 2011 Mar-Apr;56(3-4):103-9. 
17. Haney AF, Hesla J, Hurst BS, Kettel LM, Murphy AA, Rock JA, et al.. Expanded 
polytetrafluoroethylene (Gore-Tex Surgical Membrane) is superior to oxidized regenerated 
cellulose (INTERCEED TC7+) in preventing adhesions. Fertil Steril.1995 May;63(5):1021-6. 
18. Franklin RR. Reduction of ovarian adhesions by the use of INTERCEED. Ovarian Adhesion Study 
Group. Obstet Gynecol. 1995 Sep;86(3):335-40. 
19. The efficacy of INTERCEED (TC7)* for prevention of reformation of postoperative adhesions on 
ovaries, fallopian tubes, and fimbriae in microsurgical operations for fertility: a multicenter study. 
Nordic Adhesion Prevention Study Group. Fertil Steril. 1995 Apr;63(4):709-14. 
20. Mais V, Ajossa S, Piras B, Guerriero S, Marongiu D, Melis GB. Prevention of de-novo adhesion 
formation after laparoscopic myomectomy: a randomized trial to evaluate the effectiveness of an 
oxidized regenerated cellulose absorbable barrier. Hum Reprod. 1995 Dec;10(12):3133-5. 
21. Mais V, Ajossa S, Marongiu D, Peiretti RF, Guerriero S, Melis GB. Reduction of adhesion 
reformation after laparoscopic endometriosis surgery: a randomized trial with an oxidized 
regenerated cellulose absorbable barrier. Obstet Gynecol. 1995 Oct;86(4 Pt 1):512-5. 
22. 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. 
23. Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, 
Moriya Y, Laurberg S, den Dulk M, van de Velde C, Büchler MW. Definition and grading of 
anastomotic leakage following anterior resection of the rectum: a proposal by the International 
Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. 

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APPENDIX 2: LIST OF MODELS/SPECIFICATIONS 
M4345; M4350; M4350N