A Randomized, Controlled, Post-market Clinical Investigation to Evaluate Zip Surgical Skin Closure Device in Comparison of Using Standard of Care Sutures for Laceration Repair in Pediatrics in an Emergency Department
Phase: NA
Conditions: Laceration of Skin
Sponsor: ZipLine Medical Inc.

 
 
 
 
 
 
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CONFIDENTIAL 
 
CLINICAL INVESTIGATION PLAN (CIP) 
 
CLINICAL INVESTIGATION TITLE: 
A randomized, controlled, post-market clinical investigation to evaluate Zip Surgical Skin 
Closure Device in comparison of using Standard of Care sutures for Laceration Repair in 
Pediatrics in an Ambulatory and Emergency Department 
CLINICAL INVESTIGATION CODE: 
 
INVESTIGATIONAL DEVICE: 
Zip® 4 Surgical Skin Closure Device  
PRINCIPLE INVESTIGATOR: 
Dr Uri Balla ,  
Director of Pediatric emergency medicine 
Kaplan Medical Center  
Reovot, Israel 
SPONSOR:  
ZipLine Medical, Inc. 
747 Camden Ave., Suite A 
Campbell, CA 95008 
USA 
DATE: 
 
 
Version 
Revision history 
2 
 מתאריך
13/07/2018
 
 
 
 
CONFIDENTIAL 
This Clinical Investigation Plan contains privileged or confidential information, which is the property of the 
Sponsor. Information may not be disclosed to a third party without written authorization from the Sponsor. 

 
 
 
 
 
 
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1 
SYNOPSIS 
 
NAME OF THE SPONSOR: 
ZipLine Medical, Inc. 
747 Camden Ave., Suite A 
Campbell, CA 95008 
USA 
CLINICAL INVESTIGATION TITLE: 
A randomized, controlled, post-market clinical investigation to evaluate Zip Surgical Skin Closure Device in 
comparison of using Standard of Care sutures for Laceration Repair in Pediatrics in a Pedaitric Emergency 
Medicine Department 
CLINICAL INVESTIGATION CODE: 
 
INVESTIGATIONAL DEVICE: 
Zip® 4 Surgical Skin Closure Device  
AIM:  
To evaluate the Zip 4 Surgical Skin Closure Device in a pediatric population requiring laceration repair in an  
Emergency department.  
 
OBJECTIVES: 
Primary Objective 
- 
The primary objective of this clinical investigation is to evaluate the time and costs savings of the 
Zip 4 Surgical Skin Closure Device in comparison to conventional sutures used in a pediatric 
population presenting for laceration repair.  
 
Secondary Objective 
- 
The secondary objective of this clinical investigation is to evaluate the satisfaction and outcomes of 
the Zip 4 Surgical Skin Closure Device in comparison to conventional sutures used in a pediatric 
population presenting for laceration repair.  
 
OVERALL CLINICAL INVESTIGATION DESIGN: 
A prospective, randomized, controlled post-market clinical investigation that will enroll pediatric subjects 
requiring laceration repair. The investigation population will consist of 30 subjects fulfilling the eligibility 
criteria for the clinical investigation. The subjects will be randomly assigned at a 1:1 ratio to either the Zip 4 
Surgical Skin Closure Device group or the Standard of Care sutures group. The duration of the investigation 
is estimated to 6 months, including a 5-month recruitment period and 1-month follow up period.  
INCLUSION AND EXCLUSION CRITERIA: 
Inclusion Criteria 
The subjects have to meet all of the following criteria to be eligible to participate in the clinical investigation: 
1. Between 4 to 18 years of age at the time of laceration repair. 
2. Require suture closure as standard of care for simple straight wounds on trunk or extremities or face  
up to 4 cm long. 
3. Low Tension Laceration, e.g.  skin can be easily approximated by pinching with fingers. 
4. Subject and legal representative(s) are willing and able to comply with the investigational device 
removal and meet the follow up visit requirements. 
5. Subject and legal representative(s) have been informed of the nature, the scope and the relevance of 
the study. 
6. Subject and legal representative(s) have voluntarily agreed to participation and have duly signed the 
Informed Consent Form.  
 
 
 
 
 
 

 
 
 
 
 
 
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Exclusion Criteria 
Subjects meeting any of the following criteria will not be permitted to participate in the clinical investigation: 
1. Known personal or familial history of scar hypertrophy.  
2. Known or suspected allergies or hypersensitivity to non-latex skin adhesives. 
3. Atrophic skin deemed clinically prone to blistering. 
4. Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions 
(“dirty wounds”).  
5. Wounds that require deep dermal closure using sutures. 
6. Known or suspected mental problems and/or aggressiveness that indicates that the subject might try 
to remove the device during the treatment period.  
7. Participating in any other clinical investigation. 
8. Known health condition that would affect healing in the opinion of the investigator. 
9. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment. 
 
PERFORMANCE AND SAFETY ENDPOINTS: 
Primary Endpoint (performance)  
- 
The primary endpoint in this clinical investigation is the mean difference in time to wound closure 
for the two treatment methods used. These include total treatment time and duration of period 
starting from the preparation of procedure until protective wound dressing is applied, and 
including whether or not sedation was used when comparing the Zip 4 Surgical Skin Closure Device 
and the Standard of Care closure suturing.    
 
Secondary Endpoints (performance) 
- 
Difference in Wound Evaluation Score at 10 days and 30 days post-treatment compare to baseline 
when comparing scar satisfaction and appearance of the subjects receiving Zip 4 Surgical Skin 
Closure Device versus Standard of Care closure suturing. The score will be based on digital 
photographs taken on day 0, day 10 and day 30 and made by an independent panel of blinded 
physician(s).  
- 
Rate of wound healing satisfaction in subject at 30 days post-treatment when comparing Zip 4 
Surgical Skin Closure Device versus Standard of Care closure suturing. The endpoint will utilize a 
questionnaire for the subject to fill out.  
- 
The level of pain in connection to device application and removal measured by a visual analog scale 
(VAS) 0-100 mm.  
 
Secondary Endpoint (safety) 
- 
The incidence and severity of adverse events associated with the Zip 4 Surgical Skin Closure Device 
and Standard of Care closure sutures.  
STATISTICAL METHODS: 
Performance Analysis and Safety Analyses 
Statistical analysis on variables of interest, include subject demographics, baseline characteristics, 
effectiveness and safety endpoint (adverse events), will be summarized descriptively by randomization arm. 
A ”t” Test will be applied for testing the Hypothesis of the two closure methods, including ”p” values for 
statistical significance. Mean, standard deviation, range, and Coefficient of Variation (CV) will be reported 
for closure times for both the two closure treatment methods of Suture and Zip for the primary endpoint. For 
the secondary endpoints, mean, standard deviation, range, and Coefficient of Variation (CV) will be reported 
for the VAS scale data.  Additional analysis will be reported per the attribute satisfaction survey criteria 
obtained from subject satisfaction data at the 30 day follow-up interval. This will include an analysis of 
Average Satisfaction Scores, summary statistics, plus a histogram analysis comparing subject satisfaction 
data for both treatment groups of SoC sutures and Zip 4 device. 
 
 
 
 
 
 
 

 
 
 
 
 
 
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2 
TABLE OF CONTENTS 
1 
SYNOPSIS ................................................................................................................................................... 2 
2 
SPONSOR CIP APPROVAL PAGE......................................... ERROR! BOOKMARK NOT DEFINED. 
3 
TABLE OF CONTENTS ............................................................................................................................ 4 
4 
DEFINITIONS AND ACRONYMS .......................................................................................................... 7 
5 
INTRODUCTION ...................................................................................................................................... 8 
5.1 
Background ............................................................................................................................ 8 
5.2 
Clinical data ........................................................................................................................... 9 
6 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE ..................... 11 
6.1 
Manufacturer....................................................................................................................... 12 
6.2 
Identification of clinical investigational medical device ...................................................... 12 
6.3 
Device accountability/traceability ....................................................................................... 12 
6.4 
Intended purpose ................................................................................................................ 12 
6.5 
Indication and population ................................................................................................... 12 
6.6 
Manufacturing and materials .............................................................................................. 13 
6.7 
Training and experience ...................................................................................................... 13 
6.8 
Installation and use ............................................................................................................. 13 
7 
JUSTIFICATION OF CLINICAL INVESTIGATION DESIGN .......................................................... 14 
8 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL 
INVESTIGATION ............................................................................................................................................. 16 
8.1 
Anticipated clinical benefits ................................................................................................ 16 
8.2 
Anticipated risks with the device ........................................................................................ 16 
8.3 
Residual risks ....................................................................................................................... 16 
8.4 
Risks associated with participating in the clinical investigation .......................................... 17 
8.5 
Possible interactions with concomitant medical treatments .............................................. 17 
8.6 
Risk control .......................................................................................................................... 17 
8.7 
Risk-to-benefit rationale ...................................................................................................... 17 
9 
OBJECTIVES AND HYPOTHESES OF THE CLINICAL INVESTIGATION ................................. 18 
9.1 
Primary Objective ................................................................................................................ 18 
9.2 
Secondary Objectives .......................................................................................................... 18 
9.3 
Hypothesis ........................................................................................................................... 18 
9.4 
Claim of the investigational device that is to be verified .................................................... 18 
10 
DESIGN OF THE CLINICAL INVESTIGATION ........................................................................... 19 
10.1 
General ................................................................................................................................ 19 
10.2 
Primary Endpoint (performance) ........................................................................................ 20 
10.3 
Secondary endpoints (performance) ................................................................................... 20 
10.4 
Secondary endpoints (safety) .............................................................................................. 20 

 
 
 
 
 
 
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10.5 
Exposure of investigational device and standard of care .................................................... 20 
10.6 
Subjects................................................................................................................................ 20 
10.6.1 
Inclusion Criteria ......................................................................................................... 20 
10.6.2 
Exclusion Criteria ........................................................................................................ 21 
10.6.3 
Number of Subjects .................................................................................................... 21 
10.6.4 
Methods of Assigning Subjects to the different treatment arms ............................... 21 
10.6.5 
Subject withdrawal or discontinuation ....................................................................... 22 
10.7 
Clinical investigation duration ............................................................................................. 22 
10.8 
Clinical Investigation Procedures ........................................................................................ 22 
10.8.1 
Schedule of clinical investigation procedures/assessments ....................................... 22 
10.8.2 
Demographic Data and Baseline Measurements ....................................................... 25 
10.8.3 
Performance Variables and Measurements ............................................................... 26 
10.8.4 
Safety Variables and Measurements .......................................................................... 26 
10.8.5 
Potential Confounding Factors ................................................................................... 26 
10.8.6 
Prior and Concomitant Medication and Procedures .................................................. 27 
11 
DATA QUALITY ASSURANCE ....................................................................................................... 28 
11.1 
Monitoring, Audits and Inspections .................................................................................... 28 
11.2 
Subject Records and Source Data ........................................................................................ 28 
11.3 
Access to Source Data and Documentation ........................................................................ 28 
12 
STATISTICAL CONSIDERATIONS ............................................................................................... 29 
12.1 
Statistical design, method and analytical procedures ......................................................... 29 
12.2 
Sample size .......................................................................................................................... 29 
12.3 
Level of significance and power .......................................................................................... 29 
12.4 
Drop-out rates ..................................................................................................................... 30 
12.5 
Interim analysis .................................................................................................................... 30 
12.6 
Criteria for termination on statistical grounds .................................................................... 30 
12.7 
Reporting of deviations from the original Statistical Analysis Plan ..................................... 30 
12.8 
Subgroups for analysis ............................................................ Error! Bookmark not defined. 
12.9 
Procedures that take into account all the data ...................... Error! Bookmark not defined. 
12.10 
Missing, unused or spurious data ................................................................................... 30 
12.11 
Exclusion of particular information from the testing of the hypothesis ......................... 30 
13 
DATA MANAGEMENT .................................................................................................................... 31 
13.1 
Data Retention..................................................................................................................... 31 
14 
AMENDMENTS TO THE CIP ......................................................................................................... 32 
15 
DEVIATIONS FROM THE CIP ....................................................................................................... 33 
16 
STATEMENTS OF COMPLIANCE ................................................................................................. 34 
16.1 
Institutional Ethics Review .................................................................................................. 34 
16.2 
Insurance ............................................................................................................................. 34 

 
 
 
 
 
 
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17 
INFORMED CONSENT PROCESS.................................................................................................. 35 
18 
ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES ............. 36 
18.1 
Definitions ........................................................................................................................... 36 
18.2 
Methods for discovering and documenting AE/ADE ........................................................... 37 
18.2.1 
Severity ....................................................................................................................... 37 
18.2.2 
Causality ...................................................................................................................... 38 
18.3 
Methods for discovering and documenting DD .................................................................. 39 
18.4 
Reporting of SAE/SADE and DD with SADE potential .......................................................... 39 
18.5 
Data Monitoring Committee ............................................................................................... 40 
19 
VULNERABLE POPULATION ........................................................................................................ 41 
20 
SUSPENSION OR EARLY TERMINATION OF THE CLINICAL INVESTIGATION ............. 42 
20.1 
Subject follow-up ................................................................................................................. 42 
21 
PUBLICATION POLICY ................................................................................................................... 43 
22 
REFERENCES ..................................................................................................................................... 44 
23 
APPENDICES ..................................................................................................................................... 45 
23.1 
Clinical Investigation Contact List ........................................................................................ 45 
23.2 
CRF 
 
 
 

 
 
 
 
 
 
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3 
DEFINITIONS AND ACRONYMS 
 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
 
 
ASADE 
Anticipated Serious Adverse Device Effect 
CA 
Competent Authority 
CIP 
Clinical Investigation Plan 
CIR 
Clinical Investigation Report 
CV 
Coefficient of Variation 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DEHP  
di-(2-ethylhexyl)phthalate  
DD 
Device Deficiency 
DMC 
Data Monitoring Committee 
DMP 
Data Management Plan 
DMR 
Data Management Report 
DVP 
Data Validation Plan 
EEA 
European Economic Area 
EU 
European Union 
FAS 
Full Analysis Set 
FDA 
Food and Drug Administration 
ICF 
Informed Consent Form 
IEC 
Independent Ethics Committee 
ISO 
International Organization for Standardization 
MDD 
Medical Device Directive 
PI 
Principal Investigator 
PIS 
Patient Information Sheet 
PPS 
Per Protocol Set 
Residual Risk 
Risk remaining after risk control measures has been taken 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation  
SDV 
Source Data Verification 
SoC 
Standard of Care 
SOP 
Standard Operating Procedure 
USADE 
Unanticipated Serious Adverse Device Effect 
VAS 
Visual Analog Scale 
Zip device 
Zip Surgical Skin Closure Device 
WMA 
World Medical Association 
 
 

 
 
 
 
 
 
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4 
INTRODUCTION 
4.1 Background 
Every year a significant number of lacerations are managed at the Pediatric Emergency Room 
(1). Lacerations require proper skin closure in order to heal properly with good cosmetic 
outcome. Sutures are a common method for laceration closure [2]. With proper preparation of 
the wound, skilled procedure and compliant post-procedure wound care, outcomes tend to be 
favorable with good cosmetic outcome. Nevertheless, suturing takes significant time and may 
require a high degree of skill and experience [3]. The application of sutures may require 
multiple injections of anesthesia into the wound site, which may cause anxiety in patients, 
particularly in children [4]. For a child, the thought of needles and sutures may be worse than 
the actual injury itself. In some cases, pediatric patients may require sedation to reduce anxiety. 
In the patient-centered health care, it is a matter of course to increase patient satisfaction. One 
step in this direction might be to replace suturing with non-invasive methods. 
 
According to current clinical routines, suturing should in most cases be performed by 
physicians [5]. It therefore takes significant resources (time and personnel) to treat a laceration. 
From diagnosis, consultation, anesthesial injections and sedation (if required) until suturing, it 
can take more than one hour. Pediatric emergency departments often have a stressful 
environment with many patients to treat and it would be valuable if this process could be 
shortened. In addition, treated children may prefer to remove the sutures at a clinic even if it is 
usually not required with a follow up visit. This additional visit takes time for the medical staff, 
the child and the parent/guardian. Hence, a faster and more efficient treatment might reduce 
time and resources, allowing more patients to be treated at the Emergency departments.  
 
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called “Zip 
Surgical Skin Closure Device” (Zip device) as an alternative to conventional sutures, staples 
and glue for closure of the skin for surgical incisions or laceration repair. The Zip device is a 
single use, sterile medical device that is designed to provide closure speed superior to sutures, 
while resulte in a suture-like cosmetic outcome [6]. Feedback from post-market surveillance 
and evidence from published clinical studies suggest that these design intentions are correct 
[7].  
 
The Zip device has been commercially available since April 2013, with over 100.000 clinical 
cases in 30 countries in orthopedics, electrophysiology, dermatology, plastic and reconstructive 
surgery, vascular surgery, obstetrics and gynecology, and emergency medicine. Thus, the Zip 
device is not restricted to any particular procedure, and not either to a patient population. 
Randomized clinical investigations using the Zip device for skin closure in pediatric patients 
[6] as well as elderly patients [8] have demonstrated good clinical outcome.  
Not only has previous studies showed to reduce the time in wound closure, but also that the 
Zip device is less painful during removal which might be especially beneficial for a pediatric 
population [6]. The CE-mark of the Zip device was affixed in 2014 and the device is 
commercially available in Sweden today.  
 
This clinical investigation is designed to evaluate the time and costs savings and the satisfaction 
and outcomes of the Zip device when used in a Pediatric emergency department setting for 
repair of lacerations in a pediatric population. Previous studies have mainly showed the benefits 
when using the Zip device on surgical incisions, both in adults and pediatric patients, but not 
in a pediatric population requiring laceration repair. The investigation subjects will be 

 
 
 
 
 
 
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randomized to receive either the Zip device or standard of care wound closure using sutures 
for 10 days. All subjects will be followed up for 30 days after treatment.  
 
4.2 Clinical data 
Previous clinical data, both from randomized investigations, case studies and evaluations, have 
shown the value of the Zip device in terms of ease of use in a timely manner, good cosmetic 
outcome and high patient satisfaction. 
 
In 2013, a prospective case study was performed on subjects with skin excisions [9]. The results 
revealed that the Zip device was easy to use in a time efficient way with no requirements of 
advanced training to use the device effectively. The cosmetic outcome was good and high 
patient satisfaction with low ratings of pain during removal. No device-related complications 
were reported indicating the high safety of using the device.    
 
In 2014, a randomized clinical investigation was performed to compare the Zip device with 
conventional suturing on patients with basal cell carcinoma, squamous cell carcinoma or 
dysplastic nevi [10]. The outcome indicated that the Zip device has equivalent cosmetic results 
as conventional suturing while being more time efficient regarding application and removal. 
Additionally, the study showed that the device can be removed by the patient, hence 
eliminating the need for a follow up visit for device removal. 
 
During 2014 and 2015 a randomized clinical investigation was performed on pediatric patients 
who underwent cardiac operations [6]. The patients either received the Zip device or standard 
of care sutures as wound closure. The results showed that the greatest advantages with using 
the Zip device compared to sutures are the good cosmetic outcome and the reduced closure 
time. In addition, the Zip device was less painful during removal which can be particularly 
beneficial for a pediatric population.   
 
Another randomized clinical investigation was performed in 2015 where the Zip device was 
compared with subcuticular sutures on patients undergoing cardiac implantable electronic 
defibrillator [8]. Results indicated significant time savings when using the Zip device instead 
of sutures, although scar outcome, pain ratings and patient satisfaction were similar in both 
groups. 
 
A prospective evaluation was performed in 2015 on patients undergoing total knee arthroplasty 
and received the Zip device as skin closure system [11]. The results were compared to historical 
data of patients receiving sutures as wound closure. The outcome showed that the Zip device 
was easier to apply, had fewer wound complications, and that the device could be removed 
without a home care visit. 
 
In 2015, a case study was performed on two patients that received wound closure with the Zip 
device after pacemaker/implantable cardioverter defibrillator surgery [12]. The results showed 
the device to be especially useful in treatments of infection-prone patients. It was easy both to 
apply and remove and had a good cosmetic outcome. 
 
Investigations have also been performed to evaluate the Zip device in comparison to staples. 
In 2015, a randomized investigation was performed on subjects that underwent total knee 
arthroplasty and thereafter received wound closure in terms of either the Zip device or staples 

 
 
 
 
 
 
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[13]. Pain score, cosmetic outcome and wound complication rate were compared between the 
two groups. The Zip group showed less pain especially during removal of the device and better 
cosmetic outcome. There was no significant difference in wound complication rate between 
the two groups. 
 
In 2015, a case study was performed on a high-risk patient following total knee arthroplasty 
with knee surgeries over a 10-year period [14]. During the fourth revision surgery, the Zip 
device was selected as closure of the incision instead of staples due to the patient’s previous 
experience of severe pain when removing staples. The treatment with the Zip device showed 
good cosmetic outcome with a comfortable removal and no additional pain for the patient.  
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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Key Device Elements 
Company Proprietary Information 
 
16 
Adjustable Strap 
Releasable Lock 
Load Distributing Link 
Polyurethane Skirt 
Hydrocolloid Adhesive 
Release mark 
and strap 
tether 
5 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device, Zip device, to 
replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration 
repair, see Figure 1. The device is a CE-marked, single use, sterile medical device that is 
designed to provide closure speed superior to sutures, while resulting in a suture-like cosmetic 
outcome.  
 
The device is a class IIa device as per Annex II of the MDD 93/42EEC, as amended by 
Directive 2007/47/EEC. A CE-mark was affixed in 2014.  
 
 
Figure 1. Illustrations of Zip Surgical Skin Closure Device. 
 
The Zip device adheres to the skin adjacent to an incision or laceration by use of pressure-
sensitive skin adhesives. A combination of acrylic and hydrocolloid adhesives is used to 
provide a skin-friendly environment while providing the necessary tack to maintain skin 
adhesion during a maximum wear time of 14 days. In addition to the pressure-sensitive 
adhesives, the device’s closure and force distribution components are made up of polyurethane 
monofilm, polyethylene tape, polyester and nylon. Figure 2 illustrates the key elements of the 
Zip device.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2. Key components of the Zip Surgical Skin Closure Device. 

 
 
 
 
 
 
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5.1 Manufacturer 
Material fabrication, assembly, packaging and sterilization are all conducted by or for 
ZipLine Medical, Inc. in the USA.  
 
ZipLine Medical, Inc. authorized representative in the EU is:  
Emergo Europe 
Molenstraat 15 
2513 BH The Hague 
The Netherlands 
5.2 Identification of clinical investigational medical device  
Several different sizes (lengths) of the Zip device are available. In this clinical investigation, 
the smallest (4 cm) model will be used, Zip® 4 Surgical Skin Closure Device (Zip 4 device).   
 
The Zip devices are provided sterile, each in a sealed pouch designed for aseptic handoff in a 
sterile field. The devices are provided in boxes of 10 individually packaged devices, and a copy 
of the Instructions For Use (IFU) accompanies each box of 10 devices.  
 
Each device label includes the device name, part number, lot number and expiration (use by) 
date. In addition, each individual packaged Zip 4 device to be used in this clinical investigation 
will be marked “For Clinical Investigation Only, Zip-009”.  
 
The Zip 4 devices will be delivered by the Sponsor to the clinical investigation site.  
5.3 Device accountability/traceability  
The Sponsor and site personnel will keep records documenting the location of all 
investigational devices from shipment to the site, usage at the site, and return to the Sponsor 
(if applicable). This will be documented by a shipment log at the Sponsor and in a device 
accountability log at the investigation site. The device accountability log at site will include 
the following information:  
 
- 
Date, Lot No and Expiry date for each delivered device 
- 
Date and Subject No for each dispensed device 
- 
Date for each device returned to sponsor from site (if applicable) 
 
The investigational devices will be handled and stored safely, properly and in agreement with 
the provided storage conditions. Returned and unused investigational devices are accounted 
and returned to the Sponsor.  
 
The monitor will verify the accountability process at each site during the site monitoring visits. 
5.4 Intended purpose  
The Zip device is a CE-marked medical device intended for surgical incisions or laceration 
repair to approximate skin and hold together the skin edges until healing can take place. In this 
investigation, the Zip 4 device will be used for laceration repair in a pediatric population.  
5.5 Indication and population  
The Zip device is not restricted to any particular procedure or patient population. In this 
investigation, male and female subjects age 4 to 18 that present to the pediatric emergency 
department with a need of laceration repair and meet CIP eligibility criteria will be enrolled.  

 
 
 
 
 
 
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5.6 Manufacturing and materials 
The material fabrication, assembly, packaging and sterilization of the Zip device are all 
conducted by or for ZipLine Medical, Inc. The materials used for the different parts of the 
Zip device is described in Table 1 below.  
 
Table 1. Detailed description of the material used on the Zip device.  
Part of the Zip device 
Material 
Skin Adhesive 
Hydrocolloid and Acrylic 
Plastic Film 
Polyurethane 
Adjustable Straps and Locks 
Injection-Molded Nylon 
Release Liner 
Bottom: Polyethylene, Top: Paper 
 
No latex or di-(2-ethylhexyl)phthalate (DEHP) are used in the manufacturer of the Zip device.  
5.7 Training and experience 
Investigator and site personnel training will take place prior to subject enrollment to ensure 
that the Zip 4 device is used in accordance to the IFU, that complete, accurate and timely data 
are submitted, that protocol requirements are followed and that complications, adverse events 
and adverse device effects are correctly reported and investigated, as appropriate. The 
Investigator will ensure that appropriate training relevant to the clinical investigation is given 
to any other site personnel involved in the investigation and that new information of relevance 
to the performance of the investigation is forwarded to the staff involved. Staff involved in the 
research will be trained by use of a laceration simulation model and by application of the device 
on healthy volunteers.  
Staff involved in application of the device or sutures and its removal will be comprised of 
pediatric emergency physicians will clinical experience in laceration repair.  
 
It is the responsibility of Sponsor to ensure that involved staff is appropriately trained on the 
Zip 4 device. 
5.8 Installation and use 
The installation and use of the Zip 4 device shall be done according to the IFU. The Zip 4 
device shall be applied to clean, dry skin. After application of the device, the Investigator 
approximates the laceration edges and tensions the wound by adjusting the ratcheting straps 
located along the device, see Figure 3. Two to three clicks on the straps will provide light 
tension. Once the desired tension is achieved, the excess strap ends are trimmed as short as 
possible using scissors. A conventional absorptive dressing will be applied.  After application 
of the device the applying physician will judge the result (Approxiamtion. Eversion, Aversion 
etc) and if they will not be optimal the device will be removed and the subject will be treated 
by the standart of care using plain sutures.  
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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Figure 3. Adjusting Laceration Closure Tension. 
In this investigation, the Zip 4 device will remain on the skin for 10 days (+/- 2 days), at which 
point it will be removed. During this time, the subject may not use ointments containing 
petroleum as well as soak in a tub or a pool with the device on. Furthermore, the subject should 
not rub or continuously lay on the device since this may weaken the adhesives or damage the 
device. Further information is described in the IFU, and will also be explained orally for all 
participating subjects and their legal representative(s) prior discharge.  
If at the first follow up at 10 days (+/- 2 days) the treating physician will find a reason to leave 
the device for additional time to avoid gapping of the wound a new follow up for removal after 
the extra needed time appreciated by the physician will be set.  
The Zip 4 device is removed by lifting the edge of the device and gently peeling along the 
laceration, taking care not to apply stress to the laceration. If there is a risk of skin stripping, 
an adhesive removal agent may be used during the removal.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6 
JUSTIFICATION OF CLINICAL INVESTIGATION DESIGN 
The Zip device is not restricted to any specific procedure or patient population. Previous 
investigations have been performed on both young and elderly patients with incisions. Another 

 
 
 
 
 
 
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group of interest is children with lacerations; hence, this study will evaluate the Zip device in 
a pediatric population with lacerations presented to the Emergency department.  
 
Current practice of suturing in pediatrics is associated with anxiety and often requires  sedation. 
Potential benefits of the Zip device in this population includes reduced anxiety and no need for 
sedation. Treatment is expected to be easier and faster compared to suturing, efficiency and 
patient flow will be increased and satisfaction in the pediatric population will be higher. 
 
In order to answer the proposed hypothesis, that the wound closure procedure with the Zip 4 
device will result in a mean time that is significantly decreased compared to current standard 
of care for laceration repair, a prospective, randomized controlled investigation will be 
performed.  
 
Random treatment assignment will be used to minimize the risk of selection bias and to assure 
that the Zip 4 group and Standard of Care (SoC) group will be similar at the start of the 
investigation. The SoC group will be allocated from the same subject population as the Zip 4 
group. 
 
Since the Zip 4 device is a CE-marked medical device that will be used within its current 
intended use, a post-market clinical follow-up design has been deemed appropriate. As such, 
the clinical setting for this investigation will be in accordance with clinical routine at the 
investigational site including, but not limited to, preparation of subjects, as well as laceration 
closure (SoC group) and post-procedure care. The duration of the follow up has been set to 30 
days to include both healing period until removal of device and after an additional follow up 
period. 
 
 
 

 
 
 
 
 
 
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7 
RISKS AND BENEFITS OF THE INVESTIGATIONAL DEVICE AND CLINICAL INVESTIGATION 
The risk management related to the Zip device has been conducted in accordance with ISO 
14971 and included risk analysis and risk evaluation, risk control and pre-production and post-
production review. The risk management process is further described in the risk management 
report (ref doc RE10100 Rev G).  
7.1 Anticipated clinical benefits 
The potential benefits of the Zip device over standard of care closure include:  
- 
Improved cosmetic outcome 
- 
Greater patient satisfaction 
- 
No skin piercing 
- 
Reduced procedure time  
- 
Rapid one-person closure time 
- 
Eliminate need for skin sutures 
- 
Improved staff safety – reduced needle stick  
 
The investigation is intended to measure the result of some or all of these benefits.  
7.2 Anticipated risks with the device  
Complications that may occur include: 
- 
Allergic response 
- 
Infection 
- 
Dehiscence requiring intervention 
- 
Post-operative edema that may cause shearing or blistering 
- 
Wound site pain/discomfort 
- 
Skin stripping upon removal 
- 
Hypo/hyperpigmentation upon removal 
- 
Excessive scarring including: 
o Step off 
o Contour irregularities 
o Excessive distortion 
o Poor cosmetic appearance 
 
Previous evaluations have not shown any additional risks in comparison to those associated 
with existing wound closure methods [6]. Any adverse event, related as well as un-related to 
the device, will be reported in the CRF during this investigation and included in the Safety 
Analysis. 
7.3 Residual risks  
The residual risks that may occur include: 
- 
The development of post-operative edema may cause skin shearing, skin blistering or loss of 
adhesion to occur.  
- 
Application of any surgical tape or adhesive skin closure may result in skin stripping upon 
removal.   
- 
As with all adhesive products applied to the skin, a small percentage of individuals may 
experience allergic reaction and/or hypopigmentation or hyperpigmentation following 
removal.   
- 
The effect of petroleum-based ointments when used in conjunction with this device is 
unknown.   
- 
Do not use if device becomes damaged during the procedure. Risk of device failure if device 
is damaged. 

 
 
 
 
 
 
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- 
Single use device. Do not reuse. Risk of device failure or infection if reused.   
The described residual risks are understood risks associated with a non-invasive device 
intended for the closure of wounds.  
7.4 Risks associated with participating in the clinical investigation 
There are no additional risks to the subjects by participating in this clinical investigation than 
there would be if the subject was treated with the investigational device (or standard of care) 
under non-investigational settings. When comparing the risks towards the benefits of using the 
Zip device, all identified risks are considered to be acceptable. The Zip device is a CE-marked 
device delivered with IFU and will be used by trained, professional medical staff with 
experience in using the device as well as standard of care wound closure procedures. The 
reporting of adverse events and monitoring described in sections 18 and 11, respectively, will 
assure early detection of any increased risk or un-anticipated subject safety concerns.  
7.5 Possible interactions with concomitant medical treatments 
Subjects participating in the investigation should not use petroleum-based ointments in 
conjunction with the investigational device since the effects are unknown. No other interactions 
are anticipated between treatment with the investigational device and concomitant medications 
and therefore there are no further restrictions of concomitant medications. 
7.6 Risk control 
The Principal Investigator (PI) will ensure that appropriate training relevant for the 
investigation is given to the site personnel involved. The Sponsor will provide sufficient 
training on the specifics of the Zip device prior study enrollment to minimize the risks 
associated with the device. If needed, the Sponsor will visit the site several times during the 
investigation for training purpose.  
 
The Investigator and the site personnel will give care instructions to the participating subjects 
and their legal representatives prior discharge to minimize the risks after the device is placed 
and during the follow up period.  
7.7 Risk-to-benefit rationale  
In summary, when compared to the benefits of using the Zip device, there are no unacceptable 
risks of harm for the subject when used under normal conditions and within its intended use.  
The Zip 4 device is supplied with an IFU and the site personnel will be trained on the device, 
as well as subjects and their legal representatives that will be informed prior discharge about 
using and handling of the device. Based on this assessment the benefits related to the use of 
the Zip device have been shown to exceed the risks for the subjects in this clinical investigation.  
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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8 
OBJECTIVES AND HYPOTHESES OF THE CLINICAL INVESTIGATION 
8.1 Primary Objective 
The primary objective of this clinical investigation is to evaluate the time and costs savings of 
the Zip 4 Surgical Skin Closure Device in comparison to conventional sutures used in a 
pediatric population presenting for laceration repair.  
8.2 Secondary Objectives  
The secondary objective of this clinical investigation is to evaluate the satisfaction and 
outcomes of the Zip 4 Surgical Skin Closure Device in comparison to conventional sutures 
used in a pediatric population presenting for laceration repair.  
8.3 Hypothesis 
The hypothesis for the primary endpoint is: 
H0: Mean time for Zip 4 device wound closure procedure = Mean time for standard of care 
sutures wound closure procedure  
H1: Mean time for Zip 4 device wound closure procedure ≠ Mean time for standard of care 
sutures wound closure procedure 
8.4 Claim of the investigational device to be verified 
Claim: Zip device significantly reduces treatment time of lacerations in pediatric population, 
and the significant reduction translates to a cost reduction for the A&E departments.  
 
The primary endpoint will verify the time reduction of using the Zip device compared to 
standard of care sutures.  
 
The second endpoints will verify:  
- 
Physician and subject satisfaction of scar outcome and wound healing.  
- 
Pain assessment during application and removal of device. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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Zip 4 group 
SoC group 
Screening 
 Randomization           10 days           30 days   
     V1 
           V1                         FU1               FU2 
9 
DESIGN OF THE CLINICAL INVESTIGATION 
9.1 General 
This is a prospective, randomized, controlled post-market clinical investigation to compare the 
use of Zip 4 device to standard of care skin closure sutures in pediatric subjects requiring 
laceration repair. 30 subjects will be recruited 
 
The investigation consists of one screening/baseline visits at day 0 and 2 follow ups at day 10 
and day 30 (Figure 4). After written informed consent has been acquired at the 
screening/baseline visit the subject will be evaluated and checked for eligibility by a pediatric 
emergency physician with clinical experience and expertise in laceration repaiar . An eligible 
subject will be randomized (1:1) to either test or SoC group. Subjects in the test group will be 
treated with the Zip 4 device, and subjects in the SoC group will instead be treated with 
conventional sutures as wound closure. After treatment, the subject is scheduled for follow up 
10 days and 30 days post-treatment. At day 10 follow up study personnel will remove the Zip 
device or sutures. During both follow up calls at day 10 (after removal of device) and day 30, 
the subjects are assessed for the outcome of the laceration repair though subjects interviews 
and questionnaires filled out by the subject with help of their legal representative(s), if 
necessary. In addition, a blinded panel of 2 independent plastic surgeons will evaluate the 
cosmetic outcome of the laceration repair by reviewing digital photographs taken at 
screening/baseline visits versus 10 days and 30 days follow up.  
The investigation consists of one screening/baseline visits at day 0 and 2 follow ups at day 10 
and day 30 (Figure 4). After written informed consent has been acquired at the 
screening/baseline visit the subject will be evaluated and checked for eligibility. An eligible 
subject will be randomized (1:1) to either test or SoC group. Subjects in the test group will be 
treated with the Zip 4 device, and subjects in the SoC group will instead be treated with 
conventional sutures as wound closure. After treatment, the subject is scheduled for follow up 
10 days and 30 days post-treatment. At day 10 follow up study personnel will remove the Zip 
device or sutures. During both follow up calls at day 10 (after removal of device) and day 30, 
the subjects are assessed for the outcome of the laceration repair though subjects interviews 
and questionnaires filled out by the subject with help of their legal representative(s), if 
necessary. In addition, a blinded panel of 2 independent plastic surgeons will evaluate the 
cosmetic outcome of the laceration repair by reviewing digital photographs taken at 
screening/baseline visits versus 10 days and 30 days follow up.  
 
The overall duration of the clinical investigation is anticipated to be 6 months, including a 5-
month enrollment period. 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 4. Overall clinical investigation design 

 
 
 
 
 
 
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9.2 Primary Endpoint (performance) 
The primary endpoint in this clinical investigation is the mean difference in time to wound 
closure, for the two treatment methods used. These include total treatment time and duration 
of period starting from the preparation of procedure until protective wound dressing is 
applied, and including whether or not anesthesia and/or sedation was used when comparing 
the Zip 4 Surgical Skin Closure Device and the standard of care closure suturing.    
 
9.3 Secondary endpoints (performance) 
- 
Difference in Wound Evaluation Score at 10 days and 30 days post-treatment compare to 
baseline when comparing scar satisfaction and appearance of the subjects receiving Zip 4 
Surgical Skin Closure Device versus Standard of Care closure suturing. The score will be based 
on digital photographs taken on day 0, day 10 and day 30 and made by an independent panel 
of blinded two specialists in plastic surgery.  
 
- 
Rate of wound healing satisfaction in subject at 30 days post-treatment when comparing Zip 
4 Surgical Skin Closure Device versus Standard of Care closure suturing. The endpoint will 
utilize a questionnaire for the subject when possible or his caretakers to fill out.  
 
- 
The level of pain in connection to device application and removal measured by a visual analog 
scale (VAS) 0-100 mm.  
9.4 Secondary endpoints (safety) 
The incidence and severity of adverse events associated with the Zip 4 Surgical Skin Closure 
Device and Standard of Care closure sutures. 
9.5 Exposure of investigational device and standard of care  
The subjects will be exposed to either the Zip 4 device or standard of care sutures for 10 days 
(+/- 2 days) until removal. The exposure of both devices will be according to the intended use. 
Standard of care sutures has been chosen as comparison since it is the current clinical routine 
for lacerations in the pediatric population focused on in this investigation. A complete 
description of procedures and assessments performed is described in Table 3.  
 
Additional medications, i.e. sedation, local anesthesia (injection or gel) and dressing, will be 
used according to clinical routine.  
9.6 Subjects 
9.6.1  Inclusion Criteria 
The subjects have to meet all of the following criteria to be eligible to participate in the clinical 
investigation: 

 
 
 
 
 
 
 ][הקלד טקסט 
 
1. Between 4 to 18 years of age at the time of laceration repair. 
2. Require suture closure as standard of care for simple straight wounds on trunk or extremities 
up to 4 cm long.  
3. Low Tension Laceration, e.g.  skin can be easily approximated by pinching with fingers. 
4. Subject and legal representative(s) are willing and able to comply with the investigational 
device removal and meet the follow up visit requirements. 
5. Subject and legal representative(s) have been informed of the nature, the scope and the 
relevance of the study. 
6.  Subject and legal representative(s) have voluntarily agreed to participation and have duly 
signed the Informed Consent Form.  
9.6.2  Exclusion Criteria 
Subjects meeting any of the following criteria will not be permitted to participate in the clinical 
investigation: 
1. Known personal or familial history of scar hypertrophy. 
2. Known or suspected allergies or hypersensitivity to non-latex skin adhesives. 
3. Atrophic skin deemed clinically prone to blistering. 
4. Wounds that are easily susceptible to infection because of exposure to unsanitary conditions 
(“dirty wounds”).  
5. Wounds that require deep dermal closure using sutures. 
6. Known or suspected mental problems and/or aggressiveness that indicates that the subject 
might try to take to take the investigational device off. 
7. Participating in any other clinical investigation. 
8. Known health condition that would affect healing in the opinion of the investigator. 
9. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study 
enrolment. 
9.6.3  Number of Subjects 
The study population will be comprised of 60 pediatric patients presented to the Pediatric 
energency department with need of laceration repair, and eligible to study participation 
according to the inclusion and exclusion criteria. The subjects will be randomly assigned at a 
1:1 ratio to either the Zip 4 group (30 subjects) or to the SoC group (30 subjects). 
 
The sample size calculation was based on preliminary data indicating a difference of 
approximately 30 minutes in wound treatment procedures between the Zip device and SoC 
sutures. Alpha = 0.05 and power of the test = .9, indicates a sample size of 24 subjects. 
Assuming 10% dropout rate, the study will include up to 26 subjects. If for any reason the 
dropout rate should be higher than this, additional subjects might be enrolled in the study to 
reach a total of 24 completed subjects. Since different areas of the body are being appreciated 
we will enroll 60 patients.   
9.6.4 Methods of Assigning Subjects to the different treatment arms 
When the subjects are consented into the investigation they are given a unique three-digit 
identification number. If the subject is found eligible he/she will be allocated to the next 
available randomization number, a code of two digits, and the corresponding randomization 
envelope opened. The envelope contains information on group allocation in accordance with 
the randomization list. This is not a blinded investigation and both the Investigator and subject 
will be aware of the group allocation after randomization. The subject’s identification number 
and randomization number will be noted in applicable investigation logs, Case Report Form 
(CRF) and in the medical journal system for each subject 

 
 
 
 
 
 
 ][הקלד טקסט 
 
 
Subject withdrawal or discontinuation 
Subjects and/or legal representatives are free to discontinue participation in the clinical 
investigation at any time and are not required to give a reason for their decision. However, they 
that wish to discontinue the investigation should always be asked about the reason(s) for 
discontinuation and about the presence of any adverse events/adverse device effects and, if 
possible, be assessed by an Investigator. Discontinuation from the clinical investigation will 
not affect the future treatment/care of the subject.  
 
If the subject and/or legal representative(s) will withdraw the consent no further data will 
thereafter be recorded. Data collected up to the date of window and informed consent will be 
used in the data analysis and for the Clinical Investigation Report (CIR).  
 
Subjects may be withdrawn from the clinical investigation at any time, if deemed necessary by 
the PI.  
Specific reasons for withdrawal of subjects from this clinical investigation are:  
- 
The decision of a subject and/or legal representative(s) to withdraw from the clinical 
investigation (including if the subject withdraws informed consent). 
- 
The PI deems the subject is unfit for the investigation or suspects' poor CIP compliance. 
- 
Subject is lost to follow-up. 
 
In case of withdrawal, all AEs/ADEs should be followed up. Any questionnaires should be 
returned by the subject.  
 
In case of subjects lost to follow up; at least 3 documented attempts to reach the subject shall 
be made prior to categorizing the subject as “lost to follow-up”.   
 
Incorrectly enrolled or randomized subjects will be withdrawn from further investigation and 
assessments. A subject may, however, continue the clinical investigation under exceptional 
circumstances (i.e. if continuation of investigation or follow up are necessary for the subject’s 
safety and wellbeing, or if only a follow up period remain, and the continuation of the 
investigation is not expected to be associated with any risk or discomfort for the subject).  
9.7  Clinical investigation duration 
Table 2. Overview clinical investigation duration.  
Point of enrolment: 
Q2 2018 
Estimated enrolment period 
5 months 
Expected duration of each subject’s participation: 
30 days 
Total expected duration of the clinical investigation: 
6 months 
9.8 Clinical Investigation Procedures 
9.8.1  Schedule of clinical investigation procedures/assessments 
The assessments and procedures that will be performed during the clinical investigation are 
illustrated in Table 3 below.  
 
Table 3. Clinical investigation schedule for assessments and procedures.  
Study assessment 
Visit 1 
 Day 0 
 
follow-up 1 
Day 10  
(+/- 2 days) 
follow-up 2  
Day 30 
(+/- 2 days) 
Study information 
X 
 
 

 
 
 
 
 
 
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Informed consent 
X 
 
 
Demographics 
X 
 
 
Relevant Medical and Surgical history 
X 
 
 
Physical examination  
(Type, size, location of laceration) 
X 
 
 
Inclusion/Exclusion criteria  
X 
 
 
Randomization 
X 
 
 
Wound preparation, e.g. cleansing1 
X 
 
 
Local Anesthesia and/or Sedation2 
X 
 
 
Device application3 
X 
 
 
Dressing application  
X 
 
 
Study participant instructions4 
X 
 
 
Device and dressing removal5 
 
X 
 
Photographs taken6  
X 
X 
X 
Visual Analog Scale (VAS) 
X 
X 
 
Wound healing satisfaction questionnaire 
 
 
X 
Subject interview 
 
X 
X 
Adverse event 
X 
X 
X 
Medical review / Concomitant medication  
X 
X 
X 
Study Exit 
 
 
X 
1 According to clinical routine.    
2 According to clinical routine. Zip group: Anesthesia and/or sedation only use if deemed necessary by Investigator. Document in 
Concomitant Medication Log.         
3 Test group will be treated with Zip 4 device and SoC group with conventional sutures as wound closure.  
4 Instructions prior discharge regarding post-treatment and additional follow up visits.  
5 suture ir device removal will be conducted at FU session 1 at the PED or at home by a member of  staff of the study  
6 Photographs will be taken at the wound area during Visit 1and follow up visits  by the site personnel, . Please be aware of not adding any 
personal numbers or identifying characteristics on the photographs, only subject identification number and visit information.  
9.8.1.1 
Visit 1 (Screening/Baseline visit) 
The Investigator will introduce the clinical investigation and explain the CIP, procedures and 
objectives to a potential subject and their legal representative(s). The Investigator will verbally 
inform about the investigation and provide a Patient Information Sheet (PIS) describing the 
clinical investigation, potential discomforts, risks and benefits of participation. Potential 
subjects and their legal representatives will be given adequate time for review of the PIS and 
time to discuss the investigation and ask questions to the Investigator. Any queries that they 
may have regarding the investigation will be addressed appropriately by the Investigator. 
Potential subjects and their legal representatives will be instructed that they are free to obtain 
further information from the Investigator at any time and that they are free to withdraw their 
consent and to discontinue their participation in the investigation at any time without prejudice.  
 
If the subject and their legal representative(s) are willing to participate in the investigation, 
they need to sign and date the informed consent form (ICF) together with the Investigator who 
gave the verbal and written information. The original ICF will be retained in the Investigator 
Site File (ISF) and a copy provided to the subject and their legal representative(s). The 
Investigator must obtain written informed consent before any clinical investigation-related 
procedures are performed, for further details on the informed consent process please see section 
17.  
 
After written informed consent has been acquired the subject is considered as enrolled. The 
subject will be allocated to the available subject identification number, a unique three-digit 
number, used for the identification of the subject in the investigation.  
 
At visit 1 a physical examination of the laceration will be performed, and relevant 
medical/surgical history collected together with medication review and information on 

 
 
 
 
 
 
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subject’s demographics. After confirmation of the inclusion and exclusion criteria the subject 
will be randomly assigned to either test or SoC group. Subject randomization procedure will 
take place in a block randomized fashion where equal numbers of subjects will receive the Zip 
4 device and the SoC suture wound closure (1:1 ratio). The randomization will be performed 
by opening a sealed envelope containing a randomization card, for further details see section 
10.6.4. The corresponding device written in the opened randomization envelope will be used 
as laceration repair.   
 
Prior device application the wound will be cleansed, and for SoC subject local anesthesia 
and/or sedation will be used according to clinical routine. For Zip subjects, local anesthesia 
and/or sedation only will be used if deemed necessary by the Investigator. Photographs will be 
taken of the laceration by the study personnel, and thereafter the devices, Zip 4 device or SoC 
sutures, will be applied as according to the IFUs. After the devices have been applied 
appropriate, they will be covered with standard of care dressings to provide protection. 
Thereafter the subject will fill out the Visual Analog Scale (VAS) with assistance from the 
legal representative(s), if needed.  
Prior discharge: 
- 
Post-treatment information of the Zip 4 device or SoC sutures. The subjects and their legal 
representative(s) in the Zip 4 group will be informed that the subjects may not use ointments 
containing petroleum as well as reframe from soaking the device during baths or in swimming 
pools. Furthermore, the subject should not rub or continuously lay on the device since this 
may weaken the adhesives or damage the device.  
- 
Removal of the Zip 4 device or SoC sutures will be conducted by the a study personnel either 
at Kaplan Medical Center ER or at the subjects home depending on the subjects preferences.   
- 
The subject and their legal representative(s) will receive verbally and written information 
regrding the photgraphs that will be taken at day 10 and day 30.  
- 
The subject and their legal representative(s) will receive questionnaires to be filled out at day 
10 (VAS) and day 30 (Wound healing satisfaction questionnaire).  
- 
The subject and their legal representative will be given contact information to the site in case 
of an adverse event or general questions concerning the investigation.  
- 
Follow up visits will be scheduled and the subject and their legal representative(s) will be 
reminded of the importance of attending . These will be done either at the subjects home or 
at the Pediatric Emergency Department at Kaplan Medical Center.  
 
During Visit 1 the following assessments/procedures will be performed:   
- 
Demographics 
- 
Relevant medical and surgical history 
- 
Physical examination of the laceration (type, size, location) 
- 
Medication review 
- 
Verification of subject eligibility (check inclusion/exclusion criteria) 
- 
Randomization 
- 
Wound preparation, e.g. cleansing. 
- 
Anesthesia (if required) 
- 
Sedation (if required) 
- 
Photographs taken at the wound prior device application 
- 
Device application 
- 
Dressing application 
- 
VAS 
- 
Study participant instructions: hand out Zip device removal instructions and photograph 
instructions 

 
 
 
 
 
 
 ][הקלד טקסט 
 
- 
Hand out questionnaires (VAS and Wound healing satisfaction questionnaire) and self-
addressed envelopes to be filled out in conjunction with the telephone follow up 1 and 2.  
- 
Telephone follow ups scheduled 
9.8.1.2 
Follow up 1 (Day 10 +/- 2 days) 
At the first follow up  the device, either Zip 4 device or SoC sutures will removed at day 10(+-
2 days).  Prior discharge at visit 1 the subjects will receive instructions that if: 
1) Treated with Zip 4 device the subject and their legal representative(s) will remove the subject 
themselves at day 10. If necessary, the subject/legal representative(s) may call the A&E for 
assistance during the removal.  
2) Treated with SoC sutures the subject and their legal representative(s) will visit the Pediatric 
Emergency Department or at home for removal of the sutures. During the follow up after 
device removal the subject will be asked about any adverse events that may have occurred, 
and a review of the concomitant medication. The subject will be interviewed about the usage 
of the device, and will fill out the questionnaire, VAS, and photograph the laceration. Next 
follow up day 30 will be scheduled if not done at visit 1.  
 
All of the above can be done in assistance by the legal representative(s), if needed.  
 
The following assessments/procedures will be performed at follow up 1: 
- 
Subject interview 
- 
VAS 
- 
Cosmetic Outcome  
o High definition photos will be taken of the laceration  
- 
Registration of any Adverse Events 
- 
Registration of Concomitant Medication 
9.8.1.3 
Follow up 2 (Day 30 +/- 2 days) 
At the second follow up the subjects will be asked about any adverse events that may have 
occurred and a review of concomitant medication. The subjects will fill out the questionnaire, 
Wound healing satisfaction, and a subject interview will be performed by the site personnel. 
Photographs will be taken on the laceration.   
 
All of the above can be done in assistance by the legal representative(s), if needed.  
 
If no pending adverse events the subjects will be assessed as completed and the subject 
termination page will be filled out in the CRF by the site personnel after the telephone call has 
been performed.  
 
The following assessments/procedures will be performed at follow up 2:  
- 
Subject interview 
- 
Wound healing satisfaction questionnaire  
- 
Cosmetic Outcome  
o High definition photos will be taken of the laceration 
- 
Registration of any Adverse Events 
- 
Registration of Concomitant Medication 
9.8.2  Demographic Data and Baseline Measurements 
The demographic data that is collected at the screening/baseline visit will describe the subject 
population and confirm eligibility. The age, gender and weight will be recorded. In addition, 

 
 
 
 
 
 
 ][הקלד טקסט 
 
relevant medical and surgical history, medicine review and physical examination of the 
laceration prior treatment.  
 
Relevant medical and surgical history is defined as any previous or existing condition that may 
potentially affect the outcome of the treatment according to the best judgement of the 
investigator.  
9.8.3  Performance Variables and Measurements 
9.8.3.1 
Time of treatment procedure 
The treatment procedure time will be measured at the baseline/screening visit. The time will 
be recorded starting from the preparation of the wound until the protective wound dressing is 
applied. The time will be measured in HH:MM:SS, e.g. 01:15:30, and recorded in each 
subject’s CRF.  
9.8.3.2 
Wound Evaluation Score (WES) –  
The Wound Evaluation Score (WES) will be used to evaluate the scar satisfaction and 
appearance based on the photographs taken at day 0, day 10 and day 30. An independent 
panel of 2 Plastic Surgeons will objectively rate the photographs based on six categories. For 
each category, response is binary: either yes=0 or no/no=1.  
9.8.3.3 
Wound healing satisfaction  
The wound healing satisfaction questionnaire will be filled out by the subject with assistance 
by the legal representative(s) if needed. The questionnaire will be used to achieve a subjective 
evaluation of the wound healing. The questionnaire will be filled out at day 30, and contain 
questions where the subject either will mark the most correct answer or rate on a line between 
0-100 mm.   
9.8.3.4 
Visual Analog Scale (VAS) 
The pain VAS is an instrument to measure pain intensity (15) to access the subject’s subjective 
experience. The scale in this investigation will be between 0-100 mm, where 0 is no pain and 
100 mm is the worst imaginable pain for the subject. The subject will fill out the VAS line at 
the point that represents their pain intensity at the time. The VAS will be used after device has 
been applied at day 0, and after device removal at day 10. Legal representative(s) will assist if 
needed.  
9.8.4  Safety Variables and Measurements 
The safety measurement will be the onset, severity, duration and frequency of adverse events 
(anticipated and unanticipated), including determination of causality. The adverse event 
recordings between the two device groups will be compared. Only events, which are new after 
the consent has been signed or have increased in severity after the consent has been signed, 
will be recorded and used in the comparison. All adverse events will be recorded and reported 
and all data required both to assess the safety and to comply with the Competent Authority 
(CA) and IEC requirements will be collected.  
9.8.5  Potential Confounding Factors 
- 
Dressings will be used on the devices to provide protection, e.g. of accidental loss of device. 
If the device would be accidentally lost prior to complete healing process the outcome may 
be less favorable for the subject.   

 
 
 
 
 
 
 ][הקלד טקסט 
 
- 
Petroleum based ointments in conjunction with the Zip 4 device should not be used since the 
effects are unknown. 
9.8.6  Prior and Concomitant Medication and Procedures 
The site personnel will record the concomitant medication (using generic names) information 
in the appropriate section of the CRF.  
 
Note that petroleum based ointments shall not be used in conjunction with this Zip device since 
the effects are unknown.  
 
No other interactions are anticipated between treatment with the investigational device and 
concomitant medications and therefore there are no restrictions of concomitant medications. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 ][הקלד טקסט 
 
10 DATA QUALITY ASSURANCE 
10.1 Monitoring, Audits and Inspections 
During the investigation, the monitor will have regular contacts with the investigation site. 
These contacts will include visits to confirm that the facilities remain adequate to specified 
standards and that the site personnel are carrying out the procedure as stated in the CIP. All 
data must be accurately recorded in the CRF. Source Data Verification (SDV), a comparison 
of data in the CRF with the subjects’ medical records and other records of source data at the 
investigation site, will also be performed. The CRF and source documents and records must be 
made accessible during the visit.  
 
The monitor and other Sponsor personnel will be available between visits if the PI or other site 
personnel needs information and/or advice. Authorized representatives of the Sponsor and/or 
appropriate regulatory agencies, including IEC, may visit the site to perform audits/inspections, 
including SDV. 
 
A detailed description of the monitoring activities will be explained in investigation specific 
monitoring plan.  
10.2 Subject Records and Source Data 
Subject data recorded directly in the CRF, and not into the medical record, will be considered 
as source data. It is the responsibility of the PI to record essential information in the medical 
records, in accordance with national regulations and requirements. The origin of the source 
data in this clinical investigation will be further specified in a separate document (“Origin of 
Source Data”).  
 
In general, the following information will be recorded in the medical records: 
- 
Clinical investigation code 
- 
Subject identification number 
- 
That informed consent for participating in the clinical investigation was obtained 
- 
Diagnosis 
- 
All visits during the investigation period 
- 
All AEs/ADEs 
- 
Treatments and medications 
 
In the instance where the CRF is considered source data it should be noted on the ”Origin of 
Source Data” document. The PI is responsible for ensuring the accuracy; completeness, 
legibility and timeliness of the data recorded in the CRFs. Completed sections of CRFs will be 
monitored and collected on regular basis.  
10.3 Access to Source Data and Documentation 
The PI should guarantee access to source documents for the monitor and auditors as well as for 
inspection by appropriate regulatory agencies, and the IEC, if required.  
 

 
 
 
 
 
 
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11 STATISTICAL CONSIDERATIONS 
11.1  Statistical design, method and analytical procedures 
Statistical analysis on variables of interest, including subject demographics, baseline 
characteristics, effectiveness and safety endpoints will be summarized descriptively by 
randomization arm. Students ’t’ Test for comparative testing, will address testing the 
hypothesis statements, along with p values reported for significance. Mean, standard deviation, 
range, and Coefficient of Variation (CV) will be reported for closure times for both the two 
closure treatment methods of SoC suture and Zip 4 device for the primary endpoint.  
 
For the secondary endpoints, mean, standard deviation, range, and CV will be provided for the 
VAS scale data, plus comparative “t” test will be applied for testing any possible significant 
differences between the two treatment groups.  Additional analysis will be reported per the 
attribute satisfaction survey criteria obtained from patient satisfaction data at the 30 day follow-
up interval. This will include an analysis of Average Satisfaction Scores, summary statistics, 
plus a histogram analysis comparing patient satisfaction data for  both treatment groups of 
Sutures and Zipline.. 
11.2  Sample size 
Sample sizes for the two treatment groups of Zip 4 device and SoC suture, were determined, 
and based on prior studies performed for the primary endpoint of mean times for incision 
closure time. The justification for sample sizes determined, is based on the following delta 
differences, and pooled Standard Deviation (SD) calculations for mean time differences of 
closure methods. 
 
Differences and variances are based on prior data, with a delta difference of 30 mins, pooled 
SD = 22, alpha error = .05, power of the test = .9, the sample size determined for each grouis 
12, or 24 subjects total.  In consideration is a possible 10% loss calculation, a total maximum 
number of up 26 subjects or up to a maximum of 13 subjects per group is determined.  
 
11.3 Data Sets to be analyzed 
a. Safety data will include all relevant safety data from consenting subjects in this investigation.  
b. The Full Analysis Set (FAS) will include randomization (random order) of participant subjects 
in the study. 
c. The Per Protocol Set (PPS) will include the following: 
I. 
Randomization applied to participating subjects 
II. 
Completion of PPS to the study endpoint objectives in accordance with this  
Protocol. This to be performed without any significant protocol deviations, which  
could have potential erroneous affect on the studies’ efficacy, e.g. protocol 
violation could be a change to specific criteria per the primary and secondary 
endpoints. 
The final criteria specified per the PPS, regarding protocol deviations, if any,  
that warrant exclusion, will be determined at the time of the database “lock 
meeting,” when all data on any protocol violations or deviations are revealed. 
11.4  Level of significance and power 
The level of significance, or alpha error selected is equal to .05, which is interpreted as the 
Type I error for acceptance of Alternative Hypothesis or H1, with 95% confidence. The power 

 
 
 
 
 
 
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of the test, is set at .9, which is interpreted as the Type II error (beta), rendering an error of .1 
or 10% for incorrect acceptance of the Null Hypothesis or H0. 
11.5  Drop-out rates 
The drop-out rate or “Loss” is based on a 10% loss (L) estimate for this study. 
Loss calculation = (sample n/ (1-L). 
11.6  Interim analysis 
At the 10 day interview and data gathering point, an Interim Analysis will provide any 
meaningful subject feedback or inputs to VAS scores. Additionally, closure time data will be 
available at that time, for an initial analysis of the Primary Endpoint with mean, standard 
deviation, and ”t” significance testing of the Hypotheses. 
11.7  Criteria for termination on statistical grounds 
The criteria applicable for termination is based only if an incomplete study subject sample size 
taken from the population, i.e. not meeting the sample sizes (n) specified for this study, or if 
the randomization methodology (order) is not adhered to during the administration of the 
investigation. 
11.8  Reporting of deviations from the original Statistical Analysis Plan 
Any deviation discovered throughout the study from the original Statistical Analysis Plan 
(SAP), will be described with justification in a CIP Amendment to the final report, as deemed 
appropriate.  
11.9 Missing, unused or spurious data 
Spurious data, also known as outliers or mavericks, will be included in the summary tables, 
though noted in study as abnormal data. Premature withdrawn subject data will also be 
inclusive to the analysis, as far into the study as possible. Any missing data discovered will be 
incorporated to the analysis, and noted accordingly. 
11.10 Exclusion of particular information from the testing of the hypothesis 
Since the primary endpoint and the testing of the hypothesis is based specifically on mean 
closure times, there may be exclusion of extraneous data or information not related to the 
hypotheses being tested, if applicable. 
 
 
 

 
 
 
 
 
 
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12 DATA MANAGEMENT 
Data management will be conducted in accordance with applicable guidelines. A study specific 
Data Management Plan (DMP) will describe in detail the management of all subject data 
collected in the study.  Any deviations, i.e. discrepancies and additions from the procedures 
defined in the DMP, will be described in a study specific Data Management Report (DMR).  
 
All subject data will be collected in designated paper CRF and questionnaires.  The PI or an 
authorized person will record subject data in the CRF in a precise and accurate manner. 
Abbreviations should not be used. The PI is responsible for the data entered and sign off the 
CRF at the end of the clinical investigation. The data should be recorded as soon as they are 
generated.  
 
The subject data will be entered into a designated MS SQL database on a secure PFT. The 
database will be designed for the sole purpose of compiling and handling data from the ZipLine 
Study.  The ZipLine database will be validated prior to study data entry.  Responsible data 
management personnel will receive training and login credentials.  Single data entry type will 
be applied. 
 
Data validation/data cleaning procedures will be performed to assure validity and accuracy of 
the clinical data. These procedures consist of manual reviewing during data entry, as well as 
computerized edit checks.  For all detected errors, queries will be raised to site for identifying 
out-of-range data values, CIP deviations, incomplete or inconsistent data. 
 
Upon completion of the Zipline study, all study data will be verified from the original CRFs/ 
questionnaires and a complete data quality control of the database will be performed.  After all 
discrepancies are resolved and the reconciliation with the SAE database is done, the database 
will be locked and the data will be analyzed.  
12.1 Data Retention 
The medical file of clinical investigation subjects must be retained in accordance with local 
legislation and in accordance with the maximum period permitted by the hospital, institution 
or private practice.  
 
The Investigator shall retain all clinical investigation records during the investigation and for 
the period required by the applicable regulatory requirements or for at least 10 years after the 
premature termination or completion of clinical investigation, whichever is the longer. The PI 
must take measures to prevent accidental or premature destruction of these documents. The 
Investigator should contact the Sponsor prior to destruction of any records or reports pertaining 
to the clinical investigation to ensure they no longer need to be retained. In addition, if the PI 
leaves the hospital, he/she should provide the Sponsor with the name and address of the person 
who will look after and be responsible for the clinical investigation-related records. If the 
records will be transferred to another person/party, the transfer will be documented at the 
investigation site or at the Sponsor.  
 
 
 
 

 
 
 
 
 
 
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13 AMENDMENTS TO THE CIP 
Any change to the approved clinical investigation documents will be documented and include 
a written justification. Any effects of the implemented changes on other clinical investigation 
documents shall be evaluated and documented. If deemed necessary, affected documents shall 
be properly updated and relevant parties notified. The version number and date of amendments 
shall be documented.  
 
Proposed amendments to the CIP shall be agreed upon between he Sponsor and PI. The 
amendments shall be notified to, or approved by, the IEC.  
 
All amendments to the CIP will be documented in an amendment log and communicated to 
relevant parties.  
 
 
 

 
 
 
 
 
 
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14 DEVIATIONS FROM THE CIP 
A CIP deviation is a failure to follow, intentionally or unintentionally, the requirements of the 
CIP. Every effort should be made to comply with the requirements of the CIP and the 
Investigator is not allowed to deviate from the CIP.  
 
As required by national regulations or guidelines, requests for deviations and reports of 
deviations will be provided to the IEC if the deviation affects subject’s rights, safety and well-
being, or the scientific integrity of the clinical investigation.  
 
Under emergency circumstances deviations from the CIP may proceed without prior approval 
by the Sponsor and favorable opinion of the IEC if the rights, safety and well-being of the 
human subjects need to be protected. Such deviations will be documented and reported to the 
Sponsor and IEC as soon as possible in accordance with national regulations.  
 
When the monitor or Sponsor identifies that the PI is out of compliance, this will be notified to 
the PI in writing, with a request to correct the source of the deviation immediately. Corrective 
action will be implemented to avoid repeated non-compliance, which will usually include re-
training and may include terminating the clinical investigation at the site.  
 
The Sponsor is responsible for analyzing deviations and assessing their significance. Corrective 
action will be implemented to avoid repeated deviations, which may include suspending the 
clinical investigation, disqualify the PI. 
 

 
 
 
 
 
 
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15 STATEMENTS OF COMPLIANCE 
This clinical investigation will be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki (Appendix C). Furthermore, the clinical investigation 
will be conducted in compliance with ISO 14155:2011 and applicable regional or national 
regulations. 
15.1 Institutional Ethics Review 
The final CIP, including the final version of the ICF, must be approved or given a favorable 
opinion in writing by an IEC before enrolment of any subject into the clinical investigation. 
The PI is responsible for informing the IEC of any amendment to the CIP as per local 
requirements.  
 
Any additional requirements imposed by the IEC shall be followed.  
15.2 Insurance 
The Sponsor will be responsible for ensuring adequate insurance covering any injuries to the 
subject caused by the investigational medical device. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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16 INFORMED CONSENT PROCESS 
All subjects and legal authorized representatives will receive written and verbal information 
regarding the investigation beforehand. This will emphasize that participation is voluntary and 
that the subject may withdraw from the investigation at any time and for any reason. If new 
vital information appears during the clinical investigation the subject will be informed both 
orally and in writing. All subjects will have the opportunity to ask questions about the 
investigation and will be given sufficient time to decide whether to participate or not. Before 
any investigation-related procedures, the information consent will be signed and dated by the 
subject, their legal acceptable representative(s), and by the Investigator who gave the verbal 
and written information. 
 
The only exception to the above is if not all legal representative(s) are present at the 
investigation site at the time for consent. The additional legal representative(s) will receive 
verbal information about the investigation through the phone, and will give their oral consent 
prior to any investigation-related procedures. Signed consent will be given as soon as possible 
thereafter.  
 
The written subject information, PIS, explains that the data will be stored in a computer 
database, maintaining confidentiality in accordance with national data legislation, and that 
authorized representatives of the Sponsor, FDA, CA, and/or IEC may require direct access to 
those parts of the medical records relevant to the investigation, including medical history, for 
verification of data. Additionally, the written information specifies that data will be recorded, 
collected, processed and may be transferred (to either EEA countries and/or non-EEA 
countries). In accordance with the EU Data Protection Directive (95/46/EC), the data will not 
identify any subjects taking part in the investigation. 
 
 
 

 
 
 
 
 
 
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17 ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES 
The definitions and procedures for reporting Adverse Events (AE), Adverse Device Effects 
(ADE), Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE), and 
Unanticipated Serious Adverse Device Effects (USADE) are presented in the subsections 
below. It is outmost importance that all staff involved in the investigation is familiar with the 
definitions and procedures and it is the responsibility for the PI to ensure this.  
17.1 Definitions 
Adverse Event (AE) 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs 
(including an abnormal laboratory finding) in subjects, users or other persons whether or not 
related to the investigational medical device.  
 
Note 1: This definition includes events related to the investigational device or the comparator. 
Note 2: This definition includes events related to the procedure involved. 
Note 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices.  
 
Adverse Device Effect (ADE) 
Adverse event related to the use of an investigational medical device.  
 
Note 1: This includes any adverse event resulting from insufficiencies or inadequacies in the 
instructions of use, the development, the implantation, the installation, the operation, or any 
malfunction of the investigational medical device.  
 
Note 2: This includes any event that is a result of a use error or intentional abnormal use of the 
investigational medical device.  
 
Device Deficiency (DD) 
Inadequacy of an investigational medical device related to its identity, quality, durability, 
reliability, safety or performance. This may include malfunctions, use error, or inadequacy in 
the information supplied by the manufacturer.  
 
Serious Adverse Event (SAE) 
Adverse event that: 
a) Led to a death, injury or permanent impairment to a body structure or a body function.  
b) Let to a serious deterioration in health of the subject, that either resulted in:  
- 
A life-threatening illness or injury, or 
- 
A permanent impairment of a body structure or a body function, or 
- 
In-patient hospitalization or prolongation of existing hospitalization, or 
- 
In medical or surgical intervention to prevent life-threatening illness. 
c) Led to foetal distress, foetal death or congenital abnormality or birth defect.  
 
Note: Planned hospitalization for pre-existing condition, or a procedure required by the CIP, 
without a serious detoration in health, is not considered a serious adverse event.  
 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious 
adverse event.  

 
 
 
 
 
 
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Unanticipated Serious Adverse Device Effect (USADE) 
Serious adverse device effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report.  
 
Note: Anticipated SADE (ASADE): an effect which by its nature, incidence, severity or 
outcome has been previously identified in the risk analysis report.  
17.2  Methods for discovering and documenting AE/ADE 
All subjects will be carefully monitored for the occurrence of AEs throughout the clinical 
investigation, from the first day to the completion of follow up. Events prior to randomization 
will be considered medical history. The PI will collect safety information using non-leading 
questions such as “Have you experienced any new health problems or worsening of existing 
conditions?”. Events directly observed or spontaneously volunteered by subjects will also be 
recorded throughout the clinical investigation.  
 
Clearly related signs, symptoms and abnormal diagnostic procedure results should be grouped 
together and reported as single diagnosis or syndrome, whenever possible.  
 
All AEs, including but not limited to events reported by the subject or reported in response to 
an open question by the PI or member of the investigation team, which fall into any of the 
previously defined definitions must be recorded as an AE in the CRF and should include the 
following information:  
- 
Brief description of the event (diagnosis) 
- 
Date of event onsent (and time, if relevant) 
- 
Date of event resolution (and time, if relevant) 
- 
Severity 
- 
Seriousness 
- 
Causality assessment (i.e. relationship to medical device and/or procedure) 
- 
Event treatment  
- 
Event outcome 
 
Any AE that is ongoing when the subject is withdrawn from the investigation should be 
followed up until the AE is resolved or the PI decides that the AE is stable and no further follow 
up is needed.  
 
If the AE meets seriousness criteria it should be subject to expedited reporting as described in 
section 18.4.  
17.2.1  Severity 
Severity describes the intensity of an AE and will be assessed as:  
1. Mild: asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention 
not indicated. 
2. Moderate: minimal, local or non-invasive intervention indicated, limiting age-appropriate 
instrumental activities of daily living.  
3. Severe or medically significant by not immediately life-threatening: hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living.  
4. Life-threatening consequences; urgent intervention indicated.  
5. Death related to AE.  
 

 
 
 
 
 
 
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If an AE changes in severity, it should be reported as an AE of new severity but with the same 
description and identifier.  
17.2.2  Causality 
Causality is the relationship between the use of medical device (including the investigational 
device, the comparator and the medical – surgical procedure) and the occurrence of each AE.  
 
During causality assessment activity, clinical judgment shall be used and the relevant 
documents, such as the CIP, or the risk analysis report, shall be consulted as all the foreseeable 
SAEs and the potential risks are listed and assessed there. The presence of confounding factors, 
such as concomitant medication/treatment, the natural history of the underlying disease, other 
concurrent illness or risk factors shall also be considered.  
 
For harmonizing reports, each SAE will be classified per five different levels of causality. The 
Sponsor and the Investigator will use the following definitions to assess the relationship of the 
SAE: 
- 
Not related: relationship to the device or procedures can be excluded when: 
o The event is not a known side effect of the product category the device belongs to or 
of similar devices and procedures; 
o The event has no temporal relationship with the use of the investigational device or 
the procedure; 
o The serious event does not follow a known response pattern to the medical device (if 
the response pattern is previously known) and is biologically implausible; 
o The discontinuation of medical device application or the reduction of the levels of 
activation/exposure – when clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure), do not impact on the serious event; 
o The event involves a body-site or an organ not expected to be affected by the device 
or procedure; 
o The serious event can be attributed to another cause (e.g. an underlying or concurrent 
illness/clinical condition, an effect of another device, drug, treatment or other risk 
factors); 
o The event does not depend on a false result given by the investigational device used 
for diagnosis when applicable; 
o Harms to the subject are not clearly due to use error; 
o To establish the non-relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/procedures and the serious event. 
- 
Unlikely: the relationship with the use of the device seems not relevant and/or the event can 
be reasonably explained by another cause, but additional information may be obtained. 
- 
Possible: the relationship with the use of the investigational device is weak but cannot be 
ruled out completely. Alternative causes are also possible (e.g. an underlying or concurrent 
illness/clinical condition or/and an effect of another device, drug or treatment). Cases were 
relatedness cannot be assessed or no information has been obtained should also be classified 
as possible. 
- 
Probable: the relationship with the use of the investigational device seems relevant and/or 
the event cannot reasonably be explained by another cause, but additional information may 
be obtained. 
- 
Causal relationship: the serious event is associated with the investigational device or with 
procedures beyond reasonable doubt when: 
o The event is known side effect of the product category the device belongs to or of 
similar devices and procedures; 

 
 
 
 
 
 
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o The event has a temporal relationship with investigational device use/application or 
procedures; 
o The event involved a body-site or organ that 
▪ 
the investigational device or procedures are applied to; 
▪ 
the investigational device or procedures have an effect on. 
o The serious event follows a known response pattern to the medical device (if the 
response pattern is previously known); 
o The discontinuation of medical device application (or reduction of the level of 
activation/exposure) 
and 
reintroduction 
of 
its 
use 
(or 
increase 
of 
activation/exposure), impact on the serious event (when a clinically feasible); 
o Other possible causes (e.g. an underlying or concurrent illness/clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled 
out; 
o Harm to the subject is due to error in use; 
o The event depends on a false result given by the investigational device used for 
diagnosis, when applicable; 
o To establish the relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the serious event. 
 
The Sponsor and PI will distinguish between the AEs related to the investigational device, the 
standard of care and those related to any procedure specific to the clinical investigation. An 
AE can be related to both the procedure and the device. Complications of procedure are 
considered not related if the said procedure would have been applied to the subjects also in the 
absence of the device use/application.  
17.3 Methods for discovering and documenting DD 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety 
or performance shall be reported as a DD without unnecessary delay to the Sponsor by using 
the investigation specific DD form. The Zip device shall be returned to the Sponsor for analysis, 
if applicable. If the device has been in contact with the subject or may have been in contact 
with the subject’s bodily fluids, proper biohazard controls and labeling shall be used when 
handling and transporting the device.   
 
It is the PI’s responsibility to record every observed DD together with an assessment. The 
Sponsor shall review all DDs and determine and document in writing whether they could have 
led to a SADE. DDs that are assessed to or have SADE potential should be subjected to 
expedited reporting as described in section 18.4. 
17.4 Reporting of SAE/SADE and DD with SADE potential 
The following events are considered reportable events in according with the Medical Device 
Directive (MDD) 93/42/EEC and ISO 14155:2011: 
- 
Any SAE,  
- 
Any DD that might have led to a SAE if: 
o Suitable action had not been taken or; 
o Intervention action had not been taken or; 
o If circumstances had been less fortunate; 
- 
New findings/updates in relation to already reported events.  
 
All SAEs/SADEs and DDs that could have led to a SADE must be reported to the Sponsor 
immediately, but not later than 3 calendar days according to MEDDEV 2.7/3 after site 

 
 
 
 
 
 
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personnel’s awareness of the event, regardless of the time that may have elapsed from the time 
the event occurred.  
 
The initial report should contain as much information as possible, but as a minimum the 
following information:  
- 
Subject identification 
- 
Site contact information 
- 
Treatment arm 
- 
Date of procedure 
- 
Date of event onset 
- 
Event type (i.e. SAE or Device Deficiency with SADE potential) 
- 
Description of event 
- 
Action/treatment/subject outcome 
- 
Relationship to investigation procedure 
- 
Relationship to medical device 
- 
Unanticipated SADE (Yes/No) 
- 
Event status 
 
The Sponsor must also promptly receive a completed report. All SAEs have to be reported 
whether or not they are considered causally related to the investigational medical device.  
 
Since this is a post-market investigation all SAEs will be handled according to the Sponsors 
vigilance system and in accordance with MEDDEV 2.12/1 Guidelines on Medical Device 
Vigilance System.  
 
SAE EMERGENCY CONTACT DETAILS – Sponsor’s Medical Monitor 
Name: Dr. Elisabeth Liljensten, DDS PhD  
Phone: +46 (0) 723 611 968 
E-mail: elisabeth.liljensten@devicia.se 
17.5 Data Monitoring Committee 
Since this is a post-market clinical investigation no Data Monitoring Committee (DMC) will 
be assigned. Any serious adverse events will be part of the Sponsor’s vigilance system. The 
adverse event reporting and monitoring described in sections 18 and 11, respectively, will 
assure early detection of any increased risks or un-anticipated subject safety concerns.  
 
 
 
 
 
 

 
 
 
 
 
 
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18 Vulnerable population 
In this clinical investigation, pediatric subjects will participate in an age between 4 and 18 
years. Pediatric subjects are per se described as a vulnerable population according to ISO 
14155:2011. Therefore, also the potential subjects’ legal representatives will receive 
information both verbally and written about the study prior any decision about the subjects’ 
participation. If not all legal representative(s) are present at the time of consent, the additional 
legal representative(s) will receive oral information about the investigation and give oral 
consent. Written consent will take place as soon as possible thereafter. Both the potential 
subject and the legal representative(s) need to voluntarily agree to participate. The subject will 
be informed about the clinical investigation within his/her ability to understand, i.e. additional 
versions of the PIS have been developed to target the different ages. If the subject will have 
specific difficulties to understand the contents of participating in the clinical investigation, i.e. 
as a child may have, additional time will be given for questions regarding the investigation as 
well as consent procedure.   
 
 
 
 
 
 

 
 
 
 
 
 
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19 SUSPENSION OR EARLY TERMINATION OF THE CLINICAL INVESTIGATION 
If the clinical investigation is terminated early or suspended due to reasons for safety, the 
Sponsor will promptly inform the PI(s) and the site(s) of the termination or suspension and the 
reason(s) thereof. The IEC will also be informed promptly and provided with reason(s) for the 
termination or suspension by the Sponsor or by the PI/investigation site.  
 
In addition, CIP violations may result in termination of the clinical investigation at a site. CIP 
violations are deviations made without permission because of error or fraud/misconduct. 
Where the monitor or Sponsor identifies that the PI is out of compliance, this will be noted to 
the PI in writing, with a request to correct the source of the deviation immediately. Corrective 
actions will be implemented to avoid repeated non-compliance, including re-training. 
However, in case of repeated non-compliance despite implemented corrective actions, the 
clinical investigation will be terminated at the site.  
19.1 Subject follow-up 
If the clinical investigation is prematurely terminated, the Sponsor and the PI(s) will assure that 
the adequate consideration is given to the protection of subjects’ interest, including subject 
follow up.  
 
 
 
 

 
 
 
 
 
 
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20 PUBLICATION POLICY 
The clinical investigation will be registered in a publicly accessible database before recruitment 
of the first subject.  
 
A final report of the investigation, a ClR, will be completed, even if the investigation is 
prematurely terminated. The report will be prepared by the Sponsor according to the guideline 
presented in Annex D of ISO 14155:2011. 
 
All publications and presentations must be based upon the CIR. 
 
All information supplied by the Sponsor in connection with this investigation will remain the 
sole property of the Sponsor and is to be considered confidential information. No confidential 
information will be disclosed to others without obtaining prior consent from the Sponsor and 
will not be used except in the performance of this investigation. 
 
The PI(s) may publish results from this investigation; however, the Sponsor must first be given 
the opportunity to review any publication manuscript prior to submissions to journals, meetings 
or conferences. 
 
The Sponsor may choose to publish or present data from this investigation. If a PI is offered 
first authorship, he/she will be asked to comment and approve the publication. The Sponsor 
has the right to use the results for registrations and internal presentation and for promotion.  
 
 
 

 
 
 
 
 
 
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21 REFERENCES 
 
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2. Tejani C, Sivitz AB, Rosen MD, Nakanishi AK, Flood RG, Clott MA, Saccone PG, Luck RP. A 
comparison of cosmetic outcomes of lacerations on the extremities and trunk using absorbable versus 
nonabsorbable sutures. Acad Emerg Med. 2014 Jun;21(6):638-643.  
3. Lubowski D, Hunt D. Abdominal wound closure comparing the proximate stapler with sutures. Aust N Z J 
Surg. 1985 Aug;55(4):405-406. 
4. Vandamme E, Lemoyne S, van der Gucht A, de Cock P, van der Voorde P. LAT gel for laceration repair in 
the emergency department: not only for children?. Eur J Emerg Med. 2017 Feb;24(1):55-59.  
5. Middleton R. Suturing as an advances skill for registered nurses in the emergency department. Aust J Rural 
Health. 2006 Dec;14(6):258-262.  
6. Tanaka Y, Miyamoto T, Naito Y, Yoshitake S, Sasahara A, Miyaji K. Randomized Study of a New 
Noninvasive Skin Closure Device for Use After Congenital Heart Operations. Ann Thorac Surg. 2016 
Oct;102(4):1368-1374.  
7. Summary of pre-clinical and clinical data of the “Zip Surgical Closure Device”. Internal Report 2016, 
ZipLine Medical, Inc. 
8. Lalani CG, Schricker AA, Salcedo J, Hebsur S, Hsu J, Feld G, Birgersdotter-Green U. Cardiac device 
implant skin closure with a novel adjustable, coaptive tape-based device. Pacing Clin Electrophysiol. 2016 
Oct;39(10):1077-1082.   
9. Gorsylowsky DC, Talmor G. A Novel Noninvasive Wound Closure device as the Final Layer in Skin 
Closure. Dermatol Surg. 2015 Aug;41(8):987-989. 
10. Mitwalli H, Dolan C, Bacigalupi R, Khorasani H. A randomized, controlled, prospective clinical study 
comparing a novel skin closure device to conventional suturing. J Am Acad Dermatol. 2016 Jan;74(1):173-
174. 
11. Carli A. Novel non-invasive secure skin closure following total knee arthroplasty leads to fewer wound 
complications and no patient home care visits compared to surgical sutures. 2015 October. Presented at 
2015 ISTA Conference in Vienna, Austria. 
12. Maria ED. New skin closure system facilitates wound healing after cardiovascular implantable electronic 
device surgery. World J Clin Cases. 2015 Aug;3(8):675-677.  
13. Ko JH, Yang IH, Ko MS, Kamolhuja E, Park KK. Do zip-type skin-closing devices show better wound 
status compared to conventional staple devices in total knee arthroplasty?. Int Wound. 2017 Feb;14(1):250-
254. 
14. Foglar C, Dubois C. Alternative skin closure modality for highrisk patients: a case report. JBJS Journal of 
Orthopaedics for Physician Assistants. 2015 Summer;3(3):11-13. 
15. Scott J, Huskisson EC. Graphic presentation of pain. Pain. 1976 Jun;2(2):175-184.  
 

 
 
 
 
 
 
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22 APPENDICES 
22.1 Appendix– Clinical Investigation Contact List 
PRINCIPAL INVESTIGATOR 
Name:  
Uri Balla , MD. 
Address:  
Kaplan Medical Center, Rehovot Israel 
Phone: 
+972 8 9441 275 
 
+972 52 2326141 
E-mail: 
Uriballa@gmail.com 
 
CLINICAL INVESTIGATION SITE 
Kaplan Medical Center  
Rehovot  
Israel 
 
SPONSOR REPRESENTATIVE 
Name:  
Eric Storne, VP Marketing 
Address:  
ZipLine Medical, Inc. 
 
747 Camden Ave., Suite A 
 
Campbell, CA 95008 
 
USA 
Phone: 
+1 650 464 5073 
E-mail: 
estorne@ziplinemedical.com 
 
 
 
SAFETY OFFICER 
Name: 
Amir Belson, M.D.  
 
Address: 
ZipLine Medical, Inc. 
 
747 Camden Ave., Suite A 
 
Campbell, CA 95008 
 
USA 
Phone: 
+972 846 212 45 
E-mail: 
abelson@ziplinemedical.com 
 
 
 
 
 
 

 
 
 
 
 
 
 ][הקלד טקסט 
 
 
 
 
 
 
 
 
Subject ID No: 
 
|__|__|__| 
 
Sponsor: 
ZipLine Medical, Inc.  
747 Camden Ave., Suite A 
Campbell, CA 95008 
USA 
 
 
 
 
 
 
 
 
 
 
 
 
Instructions how to complete the Case Report Form 
 
• Use a ball point pen 
CASE REPORT FORM 
 
Clinical Investigation Title: 
A randomized, controlled, post-market clinical investigation to 
evaluate Zip Surgical Skin Closure Device in comparison of 
using Standard of Care sutures for Laceration Repair in 
Pediatrics in a Pediatric Emergency Department 
 

 
 
 
 
 
 
 ][הקלד טקסט 
 
• All data entries must be completed in English 
• Always use a 24-hour clock format HH:MM (e.g. 16:00) 
• Dates should be documented as follows: DD (numeric)-MMM 
(alphabetic)-YYYY (numeric). For example: 18-JUL-2014 
 
• If data is missing or impossible to obtain, please fill in as far as 
possible and fill in the remaining fields as follows: NA (not available, 
not applicable), or explain the reason why the information is 
outstanding 
 
• Data that looks inaccurate, but is correct, could be indicated with 
“sic” mark next to the information 
 
• The investigator or authorized delegate may make changes to the 
original CRFs. Corrections should be made by drawing a line over the 
incorrect item. The incorrect information must remain legible. Write 
the correct information, date for correction and your initials next to 
it.  
         
        THIS IS THE RIGHT ANSWER              NN 
Example:   THIS WAS WRONG ANSWER      18-JUL-2014 
 

 ][הקלד טקסט 
 
 ][הקלד טקסט 
 
VISIT 1 (Screening) 
Date of Visit 1 (DD-MMM-20YY) 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
INFORMED CONSENT  
Informed consent has been signed and dated by subject, legal 
representative(s) and Principle Investigator (or delegate)? 
 NO              
 YES 
 
 
Date of Obtained Informed Consent Legal Representative(s) 
(DD-MMM-20YY) 
|__|__| - |__|__|__| - |2| 0 |__|__| 
If Informed Consent was NOT obtained, please clarify:  
 
 
 
DEMOGRAPHICS 
Age 
|__|__| years 
Gender 
 
 Male        
 Female 
Weight  
|__|__| kilograms 
 
MEDICATION REVIEW 
Is the subject taking any concomitant medication? 
If YES, please fill out Concomitant Medication Log. 
 NO              
 YES  
 
RELEVANT MEDICAL AND SURGICAL HISTORY  
Any relevant medical and surgical history? If YES, please specify below.   
     
 NO            
 YES 
Medical Condition 
Details, timeline 
Ongoing 
Resolved 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PHYSICAL EXAMINATION LACERATION                                     
 
Anterior 
Posterior 

 ][הקלד טקסט 
 
 ][הקלד טקסט 
 
 
Laceration location: 
 
Please tick the box 
describing the body 
area of laceration 
location.  
 Shoulder     
 Axillary region                                                 
 Brachial arm 
 Antecubital region 
 Antebrachial arm 
 Wrist   
 Palm 
 Finger 
 Chest 
 Abdominal 
 Inguinal region 
 Hip 
 Thigh 
 Front of knee 
 Lower leg 
 Ankle 
 Dorsal side of foot  
 Toe 
 Other: _____________________ 
 Shoulder 
 Brachial arm 
 Elbow   
 Antebrachial arm 
 Dorsal side of hand 
 Back 
 Loin 
 Gluteal region 
 Thigh 
 Fold of the knee 
 Calf  
 Heel 
 Plantar 
 Other: _____________________ 
 
 
Is the laseraction on a 
bending part of the 
body? 
 NO       
 YES 
Laceration size:   
 
 
Any foreign material 
in the laceration?  
 NO       
 YES, please clarify:  
 Gravel  
 Splinter 
 Fragment of glass 
 Clothing fragment   
 Other: _______________________________________________________________ 
Laceration edges:  
 Rough/jagged 
 Smooth 
 Other: _______________________________________ 
Please provide any other relevant observations:  
 
 
 
 
INCLUSION CRITERIA 
Width _______mm 
Length _______mm 
Width 
Length 

 ][הקלד טקסט 
 
 ][הקלד טקסט 
 
1. Between 4 to 18 years of age at the time of laceration repair. 
2. Require suture closure as standard of care for simple straight wounds on trunk or extremities.  
3. Low Tension Laceration, e.g.  skin can be easily approximated by pinching with fingers. 
4. Subject and legal representative(s) are willing and able to comply with the investigational device 
removal and meet the follow up requirements. 
5. Subject and legal representative(s) have been informed of the nature, the scope and the relevance of the 
study. 
6. Subject and legal representative(s) have voluntarily agreed to participation and have duly signed the 
Informed Consent Form.  
 
EXCLUSION CRITERIA 
1. Known personal or familial history of scar hypertrophy.  
2. Known or suspected allergies or hypersensitivity to non-latex skin adhesives. 
3. Atrophic skin deemed clinically prone to blistering. 
4. Wounds that are easily susceptible to infection as a result of exposure to unsanitary conditions (“dirty 
wounds”).  
5. Wounds that require deep dermal closure using sutures. 
6. Known or suspected mental problems and/or aggressiveness that indicates that the subject might try 
to remove the device during the treatment period.  
7. Ongoing treatment with cytostatic.  
8. Known or suspected diagnosis of severe anorexia. 
9. Participating in any other clinical investigation. 
10. Known health condition that would affect healing in the opinion of the Investigator. 
11. Any subject that according to the Declaration of Helsinki is deemed unsuitable for study enrolment. 
 
ELIGIBILITY CONCLUSION 
Does the Subject fulfill all the inclusion- and none of the exclusion criteria? 
If NO – please terminate subject. 
 NO           
 YES 
 
 
 
 
Date (DD-MMM-YYYY): _________________ Investigator signature: 
______________________

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__| 
 Subject ID No     Randomization 
No 
 
 ][הקלד טקסט 
 
VISIT 1 (Randomization) 
ALLOCATION OF RANDOMIZATION NUMBER TO SUBJECT  
The subject has been allocated the following Randomization Number: |__|__|  
 
ALLOCATION OF TREATMENT  
The subject has been allocated to the following treatment group  
 Zip 4 device            
 SoC sutures  
 
VISIT 1 (Post-randomization)  
PHOTOGRAPHS TAKEN  
Photographs taken prior laceration repair 
 NO           
 YES 
If NO, please clarify:  
 
 
LACERATION REPAIR PROCEDURE 
Start Time of preparation of procedure  
 
 
Time of registration to the PED 
 
|__|__|:|__|__|:|__|__| 
             HH:MM:SS 
 
|__|__|:|__|__|:|__|__| 
             HH:MM:SS 
Wound cleaning 
Start Time of wound cleaning: |__|__|:|__|__|:|__|__|    Stop Time of wound cleaning: |__|__|:|__|__|:|__|__| 
                                                                   HH:MM:SS                                                                                         HH:MM:SS                     
Cleaning method (mark all that applies):     
 Sterile water    
 Soap     
 Removal of debris  
 Other: __________________________________________ 
Was anesthesia required for wound cleaning? 
If YES, please fill out Concomitant Medication Log.   
 NO           
 YES 
Was sedation required for wound cleaning? 
If YES, please fill out Concomitant Medication Log.    
 NO           
 YES 
Wound closure 
Was anesthesia required for wound closure?       
If YES, please fill out Concomitant Medication Log.   
 NO           
 YES, please specify:  
 No new anesthesia used, anesthesia applied during 
cleaning was adequate.  
 New or additional anesthesia required for wound 
closure.  
Was sedation required for wound closure? 
If YES, please fill out Concomitant Medication Log.   
 NO           
 YES, please specify:  
 No new sedation used, sedation applied during cleaning 
was adequate.  
 New or additional sedation required for wound closure. 
Number of Zip 4 devices used:   
(ONLY APPLICABLE FOR ZIP GROUP) 
 1   
 2   
 3   
 4    
 Other: ________   
 N/A 

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__| 
 Subject ID No     Randomization 
No 
 
 ][הקלד טקסט 
 
Wound dressing used on the device:   
 Mepore        
 Other: ____________________________    
Stope Time of procedure, i.e. after wound 
dressing been applied. 
|__|__|:|__|__|:|__|__| 
              HH:MM:SS 
Time of PED Discharge 
|__|__|:|__|__|:|__|__| 
              HH:MM:SS 
 
VAS – Visit 1 
Has the subject completed the VAS form? 
 NO           
 YES 
VAS Score _______ 
If NO, please provide reason: 
 
ADVERSE EVENT/ADVERSE DEVICE EFFECT QUESTION 
Has the subject experienced any Adverse Events/Adverse Device 
Effects during the treatment procedure? 
If YES, please fill out the Adverse Event/Adverse Device Effect Log.  
 NO           
 YES 
Has any device deficiency been detected? 
If YES, please fill out the Device Deficiency Form. 
 NO           
 YES 
 
FOLLOW UP CALLS SCHEDULED 
Follow-up 1 (10 days +/- 2 days) scheduled? (Home/PED) 
 NO           
 YES 
Follow-up 2  (30 days +/- 2 days) scheduled?(Home/ PED) 
 NO           
 YES 
 
 
 
 
Date (DD-MMM-YYYY): _________________ Investigator signature: 
_____________________

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__| 
 Subject ID No     Randomization 
No 
 
 ][הקלד טקסט 
 
FOLLOW UP 1 (10 DAYS +/- 2 DAYS) 
Date (DD-MMM-20YY) and Time 
(HH:MM) 
|__|__| - |__|__|__| - |2| 0 |__|__|                  |__|__|:|__|__| 
 
DEVICE REMOVAL 
Has the device been properly attached during the healing 
period? 
 NO           
 YES 
If NO, please provide a reason:  
Date (DD-MMM-20YY) and Time (HH:MM) of 
device removal:  
|__|__| - |__|__|__| - |2| 0 |__|__|           |__|__|:|__|__|               
Device removed as scheduled (10 days +/- 2 
days)? 
 NO           
 YES 
If NO, please provide a reason: 
Adhesive remover used for Zip 
removal? (ONLY APPLICABLE FOR ZIP 
GROUP) 
 NO           
 YES           
  N/A 
 
 
 
INTERVIEW  
If the subject would need laceration repair again, would 
the subject prefer the treatment he/she received in this 
study? 
 NO       
 YES       
 I do not know 
How satisfied is the subject with the removal procedure? 
 Very satisfied        
 Satisfied   
 Neither satisfied nor dissatisfied       
 Somewhat satisfied 
 Very dissatisfied 
Any additional comments the subject would like to 
inform about the treatment he/she received:  
 
Has the legal representative(s) helped out to answer the 
interview questions?  
 NO        
 YES     
 
 
CONCOMITANT MEDICATION QUESTION  
Has there been any new or changes to the concomitant medication since last time? 
If YES, please fill out the Concomitant Medication Log.   
 NO           
 
YES 
 

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__| 
 Subject ID No     Randomization 
No 
 
 ][הקלד טקסט 
 
ADVERSE EVENT/ADVERSE DEVICE EFFECT QUESTION 
Has the subject experienced any Adverse Events/Adverse Device Effects since last time? 
If YES, please fill out the Adverse Event/Adverse Device Effect Log.  
 NO           
 
YES 
Has any device deficiency been detected? 
If YES, please fill out the Device Deficiency Form. 
 NO           
 
YES 
 
VAS – FOLLOW UP 1  
Has the subject/legal representative(s) completed the VAS form ? 
 NO           
 
YES 
VAS Score ______ 
If NO, please provide a reason:   
 
 
 
PHOTOGRAPHING – FOLLOW UP 1  
photographs on the laceration? 
 NO           
 
YES 
If NO, please provide a reason:   
 
 
FOLLOW UP  SCHEDULED   
Has the follow up 2 (30 days +/- 2 days) been scheduled? 
 NO           
 
YES 
If NO, please provide a reason:   
 
 
 
 
Date (DD-MMM-YYYY): _________________ Investigator signature: 
_____________________

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__| 
 Subject ID No     Randomization 
No 
 
 ][הקלד טקסט 
 
FOLLOW UP 2 (30 DAYS +/- 2 DAYS) 
Date (DD-MMM-20YY) and Time 
(HH:MM) 
|__|__| - |__|__|__| - |2| 0 |__|__|                  |__|__|:|__|__| 
 
CONCOMITANT MEDICATION QUESTION  
Has there been any new or changes to the concomitant medication since last time? 
If YES, please fill out the Concomitant Medication Log.   
 NO           
 YES 
 
ADVERSE EVENT/ADVERSE DEVICE EFFECT QUESTION 
Has the subject experienced any Adverse Events/Adverse Device Effects since last 
time? 
If YES, please fill out the Adverse Event/Adverse Device Effect Log.  
 NO           
 YES 
Has any device deficiency been detected? 
If YES, please fill out the Device Deficiency Form. 
 NO           
 YES 
 
WOUND HEALING SATISFACTION QUESTIONNAIRE – FOLLOW UP PHONE CALL 2  
Has the subject completed the Wound Healing Satisfaction form ? 
 NO           
 YES 
If NO, please provide a reason:   
 
 
 
 
PHOTOGRAPHING – FOLLOW UP 2  
 photographs on the laceration? 
 NO           
 YES 
If NO, please provide a reason:   
 
 
 
 
Date (DD-MMM-YYYY): _________________ Investigator signature: 
_____________________

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__| 
 Subject ID No     Randomization 
No 
 
 ][הקלד טקסט 
 
Wound Evaluation Score (WES) Results from Photos 
BASELINE 
Date of photo evaluation(DD-MMM-20YY) 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
RESULTS 
1. Step-off of laceration edges 
   
 NONE=1             
 YES=0 ____________mm 
2. Contour irregularity - puckering 
   
 NONE=1             
 YES=0 
3. Scar width – greater than 2 mm 
   
 NONE=1             
 YES=0 
4. Edge inversion – sinking, curling 
   
 NONE=1             
 YES=0 
5. Inflammation – redness, discharge 
   
 NONE=1             
 YES=0 
6. Overall cosmesis 
   
 Acceptable=1    
 POOR=0 
- 
                                                      Total 
score:  
 
 
Additional observation/comments made by independent observer: 
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________  
 
FOLLOW UP 1  
Date of photo evaluation (DD-MMM-20YY) 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
RESULTS 
1. Step-off of laceration edges 
   
 NONE=1             
 YES=0 ____________mm 
2. Contour irregularity - puckering 
   
 NONE=1             
 YES=0 
3. Scar width – greater than 2 mm 
   
 NONE=1             
 YES=0 
4. Edge inversion – sinking, curling 
   
 NONE=1             
 YES=0 
5. Inflammation – redness, discharge 
   
 NONE=1             
 YES=0 
6. Overall cosmesis 
   
 Acceptable=1    
 POOR=0 
- 
                                                      Total 
score:  
 
 
Additional observation/comments made by independent observer: 
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________ 
  

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__| 
 Subject ID No     Randomization 
No 
 
 ][הקלד טקסט 
 
 
FOLLOW UP 2  
Date of photo evaluation (DD-MMM-20YY) 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
RESULTS 
1. Step-off of laceration edges 
   
 NONE=1             
 YES=0 ____________mm 
2. Contour irregularity - puckering 
   
 NONE=1             
 YES=0 
3. Scar width – greater than 2 mm 
   
 NONE=1             
 YES=0 
4. Edge inversion – sinking, curling 
   
 NONE=1             
 YES=0 
5. Inflammation – redness, discharge 
   
 NONE=1             
 YES=0 
6. Overall cosmesis 
   
 Acceptable=1    
 POOR=0 
- 
                                                      Total 
score:  
 
 
Additional observation/comments made by independent observer: 
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________ 
 
 
 
Date (DD-MMM-YYYY): _________________ Investigator signature: 
_____________________

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__|  
 Subject ID No   Randomization No 
 
 ][הקלד טקסט 
 
STUDY TERMINATION 
 
Date of completion or discontinuation  (DD-MMM-20YY) 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
TERMINATION BEFORE RANDOMIZATION, i.e. screening failures 
Due to inclusion or exclusion criteria, please specify: 
 Inclusion criterion      Please specify which criterion/criteria:  
__________________________________ 
 Exclusion criterion     Please specify number of criterion/criteria: 
_______________________________ 
TERMINATION AFTER RANDOMIZATION 
Study completed according to protocol?        
 NO                    
 YES          
If NO, please select one of the options below:  
 
 Unacceptable AE/ADE or SAE/SADE according to the opinion of the Investigator 
 
 The decision of a subject and/or legal representative(s) to withdraw from the 
investigation  
       (including if the subject/legal representative(s) withdraws informed consent) 
 
 Subject withdrawn by Investigator for protocol non-compliance  
 
 Subject lost to follow up. Number of attempts to contact subject/legal representative(s): 
|__|__| 
 
  Other reason, please specify:  
 
 
In case of premature discontinuation, AEs/ADEs as well as SAEs/SADEs should be 
followed up. 
 
 
 

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__|  
 Subject ID No   Randomization No 
 
 ][הקלד טקסט 
 
ADVERSE EVENT/ADVERSE DEVICE EFFECT LOG 
 
 
 
 
 
 
 
         This is the last page of the AE/ADE log 
 
No 
 
 
Description of event 
(diagnosis) 
Is this 
event 
an AE 
or 
ADE? 
Start date and Stope date 
(DD-MMM-20YY) 
 
Severity 
of 
AE/ADE  
1 Mild 
2 Moderate 
3 Severe 
Serious 
If YES, 
please 
complete 
the SAE 
Form and 
assign 
report No. 
Device 
Deficienc
y 
If YES, 
please 
complete 
the Device 
Deficiency 
Form* 
Relation-
ship  
0 Unlikely 
1 Possibly 
2 Likely 
Action taken 
0 None-required 
1 Medication** 
2 Intervention 
3 Other 
Outcome of 
AE/ADE 
1 Resolved 
2 Stable    
  condition 
3 Death 
4 Other 
01 
 
AE       
 
ADE        
Start: 
|__|__|-|__|__|__|-|2|0|__|__| 
Stop:  
|__|__|-|__|__|__|-|2|0|__|__| 
 
|__| 
YES   
NO  
                     
If YES, state 
Report No: 
__________ 
YES   
NO  
                     
 
 
|__| 
Procedur
e 
 
|__| 
Device 
 
|__| 
If 2 or 3, 
specify: 
_________________
_________________ 
 
|__| 
02 
 
AE       
 
ADE        
Start: 
|__|__|-|__|__|__|-|2|0|__|__| 
Stop:  
|__|__|-|__|__|__|-|2|0|__|__| 
 
|__| 
YES   
NO  
                     
If YES, state 
Report No: 
__________ 
YES   
NO  
                     
 
 
|__| 
Procedur
e 
 
|__| 
Device 
 
|__| 
If 2 or 3, 
specify: 
_________________
_________________ 
 
|__| 
03 
 
AE       
 
ADE        
Start: 
|__|__|-|__|__|__|-|2|0|__|__| 
Stop:  
|__|__|-|__|__|__|-|2|0|__|__| 
 
|__| 
YES   
NO  
                     
If YES, state 
Report No: 
YES   
NO  
                    
 
 
|__| 
Procedur
e 
 
|__| 
 
|__| 
If 2 or 3, 
specify: 
 
|__| 

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__|  
 Subject ID No   Randomization No 
 
 ][הקלד טקסט 
 
__________ 
Device 
_________________
_________________ 
* All device deficiencies related to the identity, quality, durability, reliability, safety or performance of an investigational medical device shall be documented.  
** Please provide information on the Concomitant Medication Log. 
Please note that an ongoing adverse event should be followed-up until the AE is resolved or until the Prinicpal Investigator decides that the AE is stable and needs no further follow up. 
CONCOMITANT MEDICATION LOG 
 
                                                    This is the last page of the CM log 
 
Please record all medications used at or during Visit 1. During follow-up calls, any changes or new medications must be recorded.  
No 
 
Generic Drug Name 
Dosage 
Indication 
> 3 months 
prior to 
study start 
* 
Start Date / Stop Date (if applicable) 
(DD-MMM-20YY) 
Ongoing 
at the 
end of 
study 
1 
 
 
 
 
 
 
 
 
Start date 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
Stop date 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
2 
 
 
 
 
 
 
 
 
Start date 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
Stop date 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
3 
 
 
 
 
 
 
 
 
Start date 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
Stop date 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
4 
 
 
 
 
Start date 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
Stop date 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 

 
 
 
 
 גרסה1
 
 מתאריך12/1/18
 
Case Report Form 
|__|__|__| - |__|__|  
 Subject ID No   Randomization No 
 
 ][הקלד טקסט 
 
5 
 
 
 
 
Start date 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
Stop date 
|__|__| - |__|__|__| - |2| 0 |__|__| 
 
 
              
                                                                                                                                                                                
 
* Start date not applicable to fill 
out if the subject has been treated 
with the medication > 3 months 

 
Confidential 
Page 62 of 63 
SIGN OFF 
 
SIGN OFF 
By signing this page, I declare that all information on page 1 – page 17 (as well as the SAE/SADE form and/or 
Device Deficiency form, if applicable) of this Case Report Form has been reviewed and is correct and complete to 
the best of my knowledge as of the date below. 
 
Date (DD-MMM-20YY): |__|__| - |__|__|__| - |2| 0 |__|__| 
 
 
Principal Investigator signature: 
 
 
Printed name of Principal Investigator: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Title: 
 
Clinical Investigation Plan 
 גרסה1
 
 מתאריך
12/1/18 
 
Confidential 
Page 63 of 63 
 
WOUND HEALING SATISFACTION QUESTIONNAIRE  
Study: ZIP-009 
 
1. How satisfied are you with your mark/scar as a result of your wound? 
a. Very Satisfied 
b. Satisfied 
c. Okay 
d. Somewhat dissatisfied 
e. Very dissatisfied 
- 
 
2. What do you think of the mark/scar as a result of your wound?  
 
 
 
 
3. How does your mark/scar feel? 
a. Very good 
b. Good 
c. Okay 
d. Not so good 
e. Very bad 
- 
 
4. How much pain do you have on your mark/scar?  
 
 
 
 
5. How did you think it was when the physician/nurse treated your wound? 
a. Very good 
b. Good 
c. Okay 
d. Not so good 
e. Very bad 
 
6. Has the guardian assisted the child in filling out the questionnaire? 
a. Yes 
b. No 
 
7. Date when the questionnaire was filled out 
 
8. Additional comments 
 
 
Very good 
Very bad 
No pain 
Worst 
i