Zip Arthroplasty Patient Satisfaction Evaluation
Conditions: Knee Arthroplasty
Sponsor: ZipLine Medical Inc.

CIP 011 
 
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CLINICAL INVESTGATIONAL PLAN (CIP) 
 
Clinical Investigation Title: 
Zip Arthroplasty Patient Satisfaction Evaluation 
Clinical Investigation Acronym: ZAPS 
Clinical Investigation Number: 
011 
Study Sponsor 
ZipLine Medical, Inc. 
747 Camden Ave, Suite A 
Campbell, CA 95008 
888-326-8999 
customerservice@ziplinemedical.com 
Principal Investigator: 
Bruce Menkowitz, MD 
 
Study Center(s): 
Montgomery Orthopaedic Assocs 
170 W Germantown Pike Ste C1 
Norristown, PA 19401 
 
Medical Monitor: 
Wendy Winters, Clinical Research Consultant  
for ZipLine Medical, Inc. 
408-506-1866 / wwinters0@gmail.com 
 
Revision History 
Date 
Author 
Changes 
2-Oct-2017 
E. Storne 
Initial Release 
 
 
 

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1 
Protocol Synopsis 
Study Purpose:  
To evaluate patient satisfaction of closure method used after joint knee arthroplasty  
Study Design: 
Prospective, randomized, single center study to evaluate Zip Closure Device in subjects 
undergoing knee arthroplasty.  
Study Endpoints 
Primary: Patient and Observer Scar Assessment Scale (POSAS) at 6 weeks post 
procedure.   
Secondary: Subject Experience and Satisfaction results at 6 weeks post procedure.   
Subject Population:  
Patients identified as candidates for knee arthroplasty and meet the study selection 
criteria  
Number of Subjects 
 40 
Number of Sites 
Single Center  
Study Procedure: 
Closure Method used immediately after Arthroplasty 
Device Name:  
Zip Surgical Closure Device 
Duration of Study 
Anticipated enrollment duration to meet sample size: ___________ 
Total Duration of Study:  ________ 
Follow-Up Schedule 
3 weeks and 6 weeks post arthroplasty surgery 
Inclusion Criteria 
1. Patients undergoing primary elective knee arthroplasty. 
2. Willing and able to provide informed consent and/or obtain legal guardian 
authorization  
3. Willing and able to comply with the subject-specific requirements outlined in the 
study protocol     
Exclusion Criteria 
1. Patients that do not meet the conditions listed in the wound closure device 
warnings, precautions, and contraindications (Appendix A) 
2. Patients with comorbidities or conditions that the investigator deems to be 
ineligible for the study 
3. Patients without the capacity to give informed consent (e.g., dementia) 
 
 
 
 

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Table of Contents 
1 
Protocol Synopsis .................................................................................................................... 2 
2 
Introduction ............................................................................................................................ 5 
2.1 
Background ....................................................................................................................... 5 
2.2 
Purpose of the study ........................................................................................................ 5 
3 
Device Description .................................................................................................................. 6 
3.1 
Device Overview ............................................................................................................... 6 
4 
Regulatory Status .................................................................................................................... 7 
4.1 
The Zip Surgical Skin Closure is a FDA Class I, 510(k) Exempt Device. ............................. 7 
4.2 
Quality System Regulations .............................................................................................. 7 
4.3 
Indication For Use ............................................................................................................ 8 
5 
Study Design............................................................................................................................ 8 
5.1 
Study Population .............................................................................................................. 8 
5.2 
Sample  Size ...................................................................................................................... 8 
5.3 
Statistical Analysis Plan .................................................................................................... 8 
5.4 
Study Criteria .................................................................................................................... 8 
5.4.1 
Inclusion Criteria ....................................................................................................... 8 
5.4.2 
Exclusion Criteria....................................................................................................... 9 
6 
Study Phases ........................................................................................................................... 9 
6.1 
Screen / Informed Consent Process ................................................................................. 9 
6.2 
Baseline Evaluation / Eligibility Determination / Enrollment ........................................ 10 
6.3 
Random Assignment ...................................................................................................... 10 
6.4 
Procedure ....................................................................................................................... 10 
6.5 
Follow Up / Study Exit .................................................................................................... 10 
6.6 
Study Evaluations and Assessments .............................................................................. 10 
7 
Subject Compensation .......................................................................................................... 11 
8 
Study Withdrawal ................................................................................................................. 11 
9 
Adverse Events ...................................................................................................................... 12 
10 
Study Size Determination .................................................................................................. 12 
11 
Methods and Procedures  ................................................................................................. 12 
12 
Risk/Benefit Assessment .................................................................................................... 13 

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13 
Quality Assurance and Supervision by Authorities ............................................................ 14 
14 
Ethical Considerations........................................................................................................ 14 
15 
Patient Confidentiality ....................................................................................................... 14 
16 
Data Analysis and Data Monitoring ................................................................................... 15 
17 
Data Storage and Confidentiality ....................................................................................... 15 
18 
Definitions and Acronyms .................................................................................................. 15 

 
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2 
Introduction 
2.1 
 Background  
Sutures and metal staples are considered standard of care methods for surgical skin closure.  The Zip® 
Surgical Skin Closure device from ZipLine Medical, Inc. (Campbell, CA USA) is a more recent method of skin 
closure that utilizes skin adhesive and adjustable ratcheting straps to achieve and maintain tension necessary 
for wound closure and healing.  The Zip device was designated Class I, 510(k) Exempt by the US FDA in 2010, 
and the CE Mark was affixed in 2014.  Clinical studies comparing the Zip device to staples and sutures have 
demonstrated several benefits, including: 
• 
Fewer wound-related readmissions compared to staples on TKA patients1 
• 
Can eliminate a home health nurse visit compared to staples on TKA patients2 
• 
3x faster wound closure compared to subcuticular sutures on pacemaker patients3 
• 
Superior cosmetic scar quality compared to subcuticular suture for pediatric cardiac sternotomy 
patients4 
• 
Less patient pain during removal compared to subcuticular suture (Prolene®) for pediatric cardiac 
sternotomy patients5 
• 
Superior protection of wound from extrinsic distraction forces compared to sutures6 
Limited patient-reported satisfaction data exists for the Zip device as compared to staples and sutures, so 
this study will attempt to address this need. 
2.2 
Purpose of the study 
To evaluate patient satisfaction of closure method used after knee joint arthroplasty.  Metal staples and the 
Zip® Surgical Skin Closure device are approved methods in regular use.  Selection of method is generally 
based on physician preference.  This study is to determine what, if any, differences exist in patient 
satisfaction amongst the two methods. 
 
 
                                                       
1 Alberto Carli, M.D., Sara Spiro, M.D., Alejandro Gonzalez Della Valle, M.D., Steven B. Haas, M.D. Hospital for Special Surgery - New York City, 
USA. Novel Non-Invasive Secure Skin Closure Following Total Knee Arthroplasty Leads to Fewer Wound Complications and No Patient Home Care 
Visits Compared to Surgical Staples. Presented at 2015 ISTA Conference, Vienna, Austria October 1, 2015 
2 ibid. 
3 LALANI, G. G., SCHRICKER, A. A., SALCEDO, J., HEBSUR, S., HSU, J., FELD, G. and BIRGERSDOTTER-GREEN, U. (2016), Cardiac Device Implant Skin 
Closure with a Novel Adjustable, Coaptive Tape-Based Device. Pacing and Clinical Electrophysiology. Accepted Author Manuscript. 
4 Tanaka Y1, Miyamoto T2, Naito Y2, Yoshitake S2, Sasahara A2, Miyaji K3. Randomized Study of a New Noninvasive Skin Closure Device for Use 
After Congenital Heart Operations. Ann Thorac Surg. 2016 May 31. pii: S0003-4975(16)30204-1. doi: 10.1016/j.athoracsur.2016.03.072. [Epub 
ahead of print] 
5 ibid. 
6 Levi K, Ichiryu K, Kefel P, et al. (October 12, 2016) Mechanics of Wound Closure: Emerging Tape-Based Wound Closure Technology vs. 
Traditional Methods. Cureus 8(10): e827. DOI 10.7759/cureus.827 

 
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3 
Device Description 
3.1 
 Device Overview 
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called “Zip Surgical Skin Closure” 
to replace sutures, staples and glue for closure of the skin layer for surgical incisions or laceration repair.  The 
device is designed to provide closure speed superior to sutures, while resulting in a suture-like cosmetic 
outcome.  Both pre-clinical feasibility study data and feedback from over 2000 human cases during the 
device’s commercial use in the USA suggest that these design intentions are correct.  This study will test 
these assertions in a controlled clinical setting, with the goal of providing results with statistical significance.     
The Zip device is a single use, sterile medical device. 
 
 
Figure 1. Zip Surgical Skin Closure Device 
 
The Zip Surgical Skin Closure Device is applied to clean, dry skin after deeper tension-relieving (i.e., dermal or 
subcutaneous) sutures have been applied. 
 
The device adheres to the skin adjacent to an incision by use of pressure-sensitive skin adhesives.  A 
combination of acrylic and hydrocolloid adhesives are used to provide a skin-friendly environment while 
providing the necessary tack to maintain skin adhesion during the recommended wear time of the device. 
The Zip device will be placed on the incision as the surgeon approximates the incision edges and tensions the 
wound by adjusting the ratcheting straps located along the device.  Once the desired tension is achieved, the 
excess strap ends are trimmed with scissors, and a conventional absorptive dressing may be applied.  The Zip 
will remain on the skin for 3 weeks, at which point it will be removed.  
 
 

 
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Figure 2. Adjusting Incision Closure Tension 
 
After application, patients may shower (but not soak in a tub or pool) with the device on.  The device is 
removed by lifting the edge of the device and gently peeling along the incision, taking care not to apply stress 
to the incision.  If there is a risk of skin stripping, an adhesive removal agent may be used during removal. 
 
 
Figure 3. Key Components of the Zip Surgical Skin Closure Device 
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. 
 
4 
Regulatory Status 
4.1 
The Zip Surgical Skin Closure is a FDA Class I, 510(k) Exempt Device. 
In 2010, ZipLine Medical, Inc. submitted a “513(g)” request for product classification to the U.S. Food and 
Drug Administration (FDA).  In July 2010, ZipLine Medical received a letter from the FDA indicating that FDA 
reviewers “believe the ZipLine 1 System falls within Title 21 of the Code of Federal Regulations (CFR) 
880.5240, Medical adhesive tape and adhesive bandage (Product Code- KGX).  A Medical adhesive tape and 
adhesive bandage is a Class I type device, exempt from the premarket notification [510(k)] requirements of 
the Act, subject to the limitations of the exemption found in 21 CRF 880.9.” 
4.2 
Quality System Regulations 
The Zip Surgical Skin Closure Devices have been developed and are manufactured in full compliance with FDA 
Title 21 CFR Part 820 Quality System Regulations, including design controls, document controls, purchasing 
controls, identification and traceability, production and process controls, acceptance activities, 
Key Device Elements 
Company Proprietary Information 
 
16 
Adjustable Strap 
Releasable Lock 
Load Distributing Link 
Polyurethane Skirt 
Hydrocolloid Adhesive 
Release mark 
and strap 
tether 

 
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nonconforming product, corrective and preventive action, labeling and package control, handling, storage, 
distribution and installation, record keeping, servicing, and statistical techniques. 
 
Origin of Manufacture:  The Zip® brand Surgical Skin Closure Devices are manufactured in the USA. 
 
Company Registration:  ZipLine Medical, Inc. is registered with the FDA in compliance with Title 21 Code of 
Federal Regulations (CFR) Part 807, Subparts A-D. 
4.3 
Indication For Use 
The Zip Surgical Skin Closure Device is indicated for use during and after skin incision procedures to 
approximate skin and hold together the skin edges until healing can take place 
 
5 
Study Design  
Prospective, randomized, single center,  study to evaluate Zip Closure Device in subjects undergoing knee 
arthroplasty.  
5.1 
Study Population 
Patients identified as candidates for knee arthroplasty and meet the study selection criteria.  
5.2 
Sample  Size  
Knee Arthroplasty of 40 subjects will be enrolled.  20 subjects will receive ZipLine and 20 subjects will receive 
Staples.   
 
5.3 
Statistical Analysis Plan 
 
General Summary  
 
All variables of interest including subject demographics, baseline characteristics, POSAS scores and patient 
satisfaction of closure method used will be summarized descriptively by assigned closure groups.   Mean, 
standard deviation, range, and Coefficient of Variation (CV) will be reported across the POSAS Scale 
attributes, plus comparative “t” test applied between the treatment groups across POSAS attributes. Results 
will include significance testing (t test) for Knee Arthroplasty study.  
5.4 
Study Criteria 
There will be no gender-based enrollment restrictions. It is expected that the proportion of male to female 
subjects will be similar to the normal proportion related to the procedure type.  
No vulnerable subjects shall be considered for enrollment.  This includes children, pregnant women, nursing 
home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with 
decisional incapacity.  
There will be no restrictions on subject age.  
There will be no restrictions or selection criteria based on subject racial and ethnic distribution.  
5.4.1 
Inclusion Criteria  
Candidates for the study must meet all the following criteria:  
 
1. Patients undergoing primary elective knee arthroplasty. 
2. Willing and able to provide informed consent and/or obtain legal guardian authorization  

 
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3. Willing and able to comply with the subject-specific requirements outlined in the study protocol 
 
5.4.2 
Exclusion Criteria 
Candidates for the study must not meet any of the following criteria.  If any one of the following is met, the 
patient is not eligible to participate in the study.  
 
1. Patients that do not meet the conditions listed in the wound closure device warnings, 
precautions, and contraindications (Appendix A) 
2. Patients with comorbidities or conditions that the investigator deems to be ineligible for the 
study 
3. Patients without the capacity to give informed consent (e.g., dementia) 
6 
Study Phases 
The study will be conducted in phases as subjects are consented, determined eligible by meeting the study 
selection criteria, receive treatment and followed as standard after the arthroplasty procedure and exited from the 
study 
6.1 
Screen / Informed Consent Process 
Patients considered to be eligible candidates for the study will be approached to understand their willingness 
and interest of volunteering for the study.  The informed consent process will then be performed in the 
following manner:  
 
Informed Consent 
Informed consent will be obtained as outlined in 21 CFR Part 50 and the Good Clinical Practice: Consolidated 
Guidance (ICH, April 1996).  
 
Eligible patients will be introduced to the study opportunity during a pre-operative visit.  Patients will be 
given the opportunity to have their questions answered, either at the time of their visit, or after the visit via 
phone or email.  Patients will be given the opportunity to provide consent at the time of their visit or at a 
later time if they need time to consider participating.  A research study member at the approved study site 
will speak with the study candidate about the purpose of the study.  Explanation of the study background, 
study procedure, follow up visit schedule, study procedure risks and benefits will be reviewed in detail with 
the patient.  Patients will be given the time they need to read through the study information and informed 
consent document and ask as many questions as necessary to make them comfortable with the study and 
the requirements.  
 
For those potential candidates who agree to participate in the study by signing the IRB approved Informed 
Consent Form (ICF), a baseline evaluation will be conducted.  Consent may be obtained by the investigator or 
staff member authorized by the investigator.   
 
If a patient does not have the capacity to give informed consent, they will be excluded from consideration for 
enrollment.  If an enrolled subject loses the capacity to reasonably complete the study questionnaire surveys 
during the study, they shall be discharged from the study.  
 
The investigator will ensure that prospective subjects have sufficient knowledge and comprehension of the 
information represented by the elements of informed consent to enable them to make an informed and 
enlightened decision whether or not to participate or allow participation in research. The investigator shall, 
based on clinical judgment, determine if the study candidate understood the information presented 
 
The investigator shall be responsible for ensuring that valid consent is obtained and documented for all 
subjects. All study records including the completed consent forms and patient satisfaction questionnaires 
shall be maintained in a secure location in the investigator’s clinic and handled in a manner that maintains 
confidentiality of the data.   

 
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6.2 
Baseline Evaluation / Eligibility Determination / Enrollment 
The study investigator or study staff member will conduct a formal evaluation for study eligibility which may 
include reviewing medical history and understanding general health.  When the subject is determined eligible 
and scheduled for the arthroplasty procedure they will be enrolled into the study.   
6.3 
Random Assignment 
The subject will be randomized to a closure assignment prior to the procedure.  A study staff member will 
open a sealed randomization envelope consisting of closure assignment and a subject study identification 
number.  The subject is considered enrolled into the study at this time and the subject disposition will be 
accounted for in study reports.    
 
Subjects will be assigned in consecutive order in a 1:1 ratio for closure assignment (Metal Staples:Zip Closure 
Device) until all subjects are enrolled.  
 
6.4 
Procedure 
Arthroplasty will be performed as standard and the assigned closure method will be applied and documented 
on the procedure Case Report Form (CRF).  Subjects will be reminded of their follow-up visits to the study 
office.  
6.5 
Follow Up / Study Exit 
The follow-up period of the study will begin after the arthroplasty procedure.  All follow-up visits will be 
scheduled from the date of the arthroplasty procedure and should be within the study visit windows as 
indicated in the Table of Assessments (Table 1).  
6.6 
Study Evaluations and Assessments 
The following assessments will be made during each study visit:  
 
 
Subject Satisfaction Questionnaire – to evaluate subject experience and outcome of incision closure 
 
POSAS (Patient and Observer Scar Assessment Scale) – the subject and investigator will rate commonly 
described scar characteristics from a patient and observers perspective.  
 
 
 

 
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           Table 1: Schedule of Assessments 
Assessments 
Screening / Baseline 
Study Procedure 
     
3-Week Follow-Up  
    (+/- 3 days) 
6-Week Follow-Up 
    (+/- 7 days) 
Screen and Informed Consent Process 
X 
 
 
 
Medical Hx, Demographics, Eligibility 
X 
 
 
 
Randomization Assignment 
X 
 
 
 
Study Procedure and Closure Method 
 
X 
 
 
Subject Satisfaction Questionnaire 
 
 
X 
X 
POSAS: Subject and Impartial rater  
Assessment 
 
 
X 
X 
Photo of closure of incision 
 
X 
X 
X 
Adverse Event review 
 
 
X 
X 
Study Exit 
 
 
 
X 
 
7 
Subject Compensation 
Participating study subjects will not incur any costs as a result of participating in the study and will not receive 
reimbursement or payments for participation.  
 
8 
Study Withdrawal 
Subjects may be terminated or withdrawn from the study for the following reasons: 
• 
Voluntary withdrawal – meaning that the subject voluntarily chooses not to further participate in the study 
• 
Lost to follow-up – meaning that the subject is more than one month late (beyond the late visit window) to 
a study visit and 3 documented attempts to contact the subject are unsuccessful.  A subject who misses a 
study visit but attends a subsequent visit will no longer be considered lost to follow-up. 
• 
In the physician’s opinion, it is not in the best interest of the subject to continue study participation. 
• 
Subject death.   
 
 
Any study subject who does not attend a scheduled follow-up visit should be contacted by site personnel to 
determine the reason for the missed appointment(s).  The reason for the missed visit should be determined and 
documented in the subject’s study records.  All subjects enrolled (including those withdrawn or lost to follow-up) 
shall be accounted for with appropriate documentation.  
 

 
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9 
Adverse Events 
Adverse events (AEs) may occur during the procedure phase or the follow-up phase of the study.  Adverse events 
occurring after the baseline assessment but before the arthroplasty procedure will be documented in the subject’s 
medical record but will not count as related to the closure device.   
Each adverse event will be recorded in the corresponding subject’s CRF.  Each adverse event will be judged by the 
Investigator as to its relationship and level of relatedness to the closure device .  In addition, the Investigator will 
identify the date of onset, severity and duration of the AE.  All adverse events will be monitored until they are 
adequately resolved or explained.  If a subject reaches the final follow-up visit and is experiencing a new or ongoing 
adverse event, the study sponsor should be contacted to discuss the need and/or methods for continued surveillance 
of the event. 
The Investigator must submit to the Sponsor a report of any Serious Adverse Event (SAE), Serious Adverse Device 
Effect (SADE) or Unanticipated Adverse Device Effect (UADE) within 24 hours of knowledge of the event. 
Sponsor Contact:   
Eric Storne  
Telephone:    
(408) 684-0747 
Mobile     
 
(650) 464-5073 
Email:  
 
estorne@ziplinemedical.com  
 
 
In addition, the Investigator will report adverse events to the reviewing IRB / EC (as applicable) according to the 
local reporting requirements. 
 
10 Study Size Determination 
Knee Arthroplasty:  2 groups:  Zipline to Staples (2 groups, paired data) with POSAS Scale data est. delta ~ 
1.5, and Est. SD ~ 1.41 
 
Alpha error = .05   
 
Power = 0.9, sample n = 19 pairs, or 38 total subjects with estimated 5% subject study loss, n = 40 total 
subjects, or 20 per group. 
 
11 Methods and Procedures  
1. Study investigator and designated staff shall be trained on study procedures by the sponsor or sponsor 
delegate. 
 
2. Patients shall be screened prior to surgery for study eligibility by the investigator or staff member 
designated by the investigator. 
 
3. Eligible patients shall be presented with the study opportunity during a pre-operative consultation visit to 
the study site, and will be given the opportunity to read the informed consent form and receive answers 
to any questions about the study.  If the patient is able and willing to participate, they will sign the 
consent form and become an enrolled subject. 
 
4. Randomization will be assigned in permuted block so that even numbers of each closure method is 
assigned 
 
5. Immediately after the arthroplasty procedure the assigned closure method will be applied and 
documented on the procedure data form 
 

 
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6. During the subject’s scheduled (i.e., standard of care) 3-week post-operative clinic visit and immediately 
AFTER the wound closure device is removed (e.g., Zip or staples), clinic staff will:  
a. Administer the first patient satisfaction questionnaire  
b. POSAS will be performed by an impartial rater   
c. 
Photograph the scar in a well-lighted room at a distance of approximately 12-14”, capturing the 
entire scar. Ensure the knee joint is flexed at approximately 45 degrees for the photo.  
 
7. During the subject’s scheduled (i.e., standard of care) 6-week post-operative clinic visit, clinic staff will: 
a. Administer the second patient satisfaction survey 
b.  POSAS will be performed by an impartial rater   
c. 
Photograph the scar in a well-lighted room at a distance of approximately 12-14”, capturing the 
entire scar.  Ensure the knee joint is flexed at approximately 45 degrees for the photo. 
 
8. Once enrollment is complete and all subjects have completed the patient satisfaction questionnaires, the 
data will be analyzed and results will be evaluated by the investigator. 
12 Risk/Benefit Assessment 
Risk Category. This is a minimal risk study. The probability and magnitude of harm or discomfort anticipated in 
the research are not greater than those ordinarily encountered in daily life or during the performance of routine 
physical or psychological examinations or tests.  
Potential risks associated with the use of the closure methods in this study as standard of care do not differ from 
those commonly used for closing wounds, incisions or lacerations.   
 
Potential risks associated with the closure methods used in this study are listed below.  Subjects will be monitored 
closely as part of this study to allow for detection of symptoms, should they be present.  This, in turn, should allow 
for early treatment or intervention, if necessary.  
The following are side effects that may occur as a result of use of closure methods used to repair incisions after the 
arthroplasty procedure:  
• 
Blistering from overtightening of the Zip Closure Device causing excessive stretch force applied to the 
epidermis 
• 
Edema which can cause skin shearing, skin blistering or loss of adhesion to occur 
• 
Skin stripping upon removal as a result of any surgical tape or adhesive applied to skin 
• 
Allergic reaction to the adhesive product including hypopigmentation or hyperpigmentation following 
removal 
• 
Infection resulting from any bacteria introduced into the incision  
• 
Dehiscence requiring intervention 
• 
Device failure / malfunction 
• 
Edema 
• 
Wound site pain / discomfort 
• 
Excessive scarring including: 
o 
Step-off 
o 
Contour irregularities 
o 
Excessive distortion 
o 
Poor cosmetic appearance  
Protection Against Risks 
This is a minimal risk study.  Nonetheless, all efforts will be made to minimize any potential risk. Risks will be 
minimized through the use of an Investigator with a high degree of experience in orthopaedic surgery.  The 
Investigator has received sponsor-led training in proper use of the device, prior to study initiation and as 
warranted throughout the study.  The sponsor will monitor the study for any trends that would indicate a safety 

 
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issue.    
Potential Risks to Patient Confidentiality  
In all clinical studies, confidentiality of protected health information may be breached due to study-related 
activities beyond those of routine clinical care.  This risk will be minimized by not collecting personally identifying 
information on Case Report Forms (CRFs) or other study-related documentation to be provided to the study 
sponsor 
Potential Benefits to the Subjects 
There are no potential benefits to the subjects other than the satisfaction of having helped improve the body of 
knowledge on the study subject, which may lead to future preference towards a superior wound closure modality 
in a subsequent surgery.  
Alternatives to Participation 
Since this is a patient-participation survey and not an experimental study, the only alternative to participation is to 
not participate.  
13 Quality Assurance and Supervision by Authorities 
This study will be conducted in accordance with elements of E6 Good Clinical Practice Consolidated Guidance, ICH, 
April 1996, abbreviated requirements of 21 CFR 812.2(b) for Non-significant Risk (NSR) device studies, the 
Declaration of Helsinki, the Belmont Report, and IRB/EC requirements. 
 
All documents and data shall be produced and maintained in such a way to assure control of documents and data to 
protect the patient’s privacy as far as reasonably practicable.  The Sponsor and representatives of the FDA or other 
regulatory authorities are permitted to inspect the study documents (e.g., study protocol, CRFs, and original study-
relevant medical records/files) as needed.  All attempts will 
be made to preserve patient confidentiality.  
 
The clinical site is subject to audit by study sponsor personnel or designee for protocol adherence, accuracy of CRFs 
and compliance with applicable regulations.  Any evident pattern of non-compliance with respect to these standards 
will be cause for corrective action. 
 
The study protocol, data-recording procedures, data handling as well as study reports are subject to an independent 
clinical Quality Assurance audit by the study sponsor, its designee, or health authorities. 
 
14 Ethical Considerations 
The rights, safety and well-being of clinical investigation subjects shall be protected consistent with the ethical 
principles outlined in the Declaration of Helsinki.  This shall be understood, observed and applied at every step in 
this clinical investigation.  
 
It is expected that all parties will share in the responsibility for ethical conduct in accordance with their respective 
roles in the investigation.  The Sponsor and the Investigator shall avoid improper influence or inducement of the 
patient, study monitor, clinical investigator or other parties participating in or contributing to the clinical 
investigation.   
 
15 Patient Confidentiality 
At all times throughout the clinical investigation, confidentiality will be observed by all parties involved.  All data 
shall be secured against unauthorized access.  Privacy and confidentiality of information about each patient shall be 
preserved in the reports and in any publication.  Each patient participating in this study will be assigned a unique 
identifier.  All CRFs will be tracked, evaluated, and stored using only this unique identifier.   

 
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The study site will maintain a confidential study patient list (paper or electronic) identifying all enrolled patients.  
This list will contain the assigned study patient’s unique identifier and name.  The Site Principal Investigator (PI) bears 
responsibility for keeping this list confidential.  This list will not be provided to the study sponsor and is only to be 
used at the study center. 
Monitors and auditors will have access to the study patient list and other personally identifying information of study 
patients to ensure that data reported in the CRF corresponds to the person who signed the ICF and the information 
contained in the original source documents.  Such personal identifying information may include, but is not limited 
to the patient’s name, address, date of birth, gender, race and medical record number.   
 
NOTE:  The patient’s name, medical record number or address will NOT be recorded in the monitor’s visit report or 
the database; demographic data that may be recorded includes age, race, and gender.   
Any source documents copied for monitoring purposes by the Sponsor will have patient identifiable information 
redacted and be identified by using the assigned patient’s unique identifier in an effort to protect patient 
confidentiality.  
 
16 Data Analysis and Data Monitoring 
The study sponsor or designated clinical research associate or professional, shall monitor the site regulatory study 
documents and study data as needed.  All study records including the completed patient satisfaction 
questionnaires shall be maintained in a secure location in the investigator’s clinic and handled in a manner that 
maintains confidentiality of the data.  Data analysis shall be performed by the study statistician using appropriate 
analysis tools.    
17 Data Storage and Confidentiality 
All study records including the completed patient satisfaction questionnaires shall be maintained in a secure 
location in the investigator’s clinic and handled in a manner that maintains confidentiality of the data.   
 
18 
Definitions and Acronyms 
Adverse Events 
 
Adverse Event (AE) – any untoward medical occurrence in a subject (ISO 14155).   
NOTE:  This definition does not imply that there is a relationship between the adverse event and the device under 
investigation. 
 
Serious Adverse Event (SAE) – an adverse event that (ISO 14155): 
• 
led to a death, 
• 
led to a serious deterioration in the health of the subject,  
• 
resulted in a life-threatening illness or injury, 
• 
resulted in a permanent impairment of a body structure or a body function, 
• 
required hospitalization or prolongation of existing hospitalization, 
• 
resulted in medical or surgical intervention to prevent permanent impairment to body structure or function, 
• 
led to fetal distress, fetal death, a congenital abnormality, or birth defect.  
 
Adverse Device Effect (ADE) – any untoward and unintended response to a medical device (ISO 14155) 
NOTE: This includes any event resulting from insufficiencies or inadequacies in the instructions for use or the 
deployment of the device.  This definition also includes any event that is a result of user error. 
 

 
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Serious Adverse Device Effect (SADE) – an adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event or that might have led to any of these consequences if suitable action had 
not been taken or intervention had not been made or if circumstances had been less opportune (ISO 14155). 
 
Anticipated Adverse Device Effect (AADE) – an adverse device effect which by its nature, incidence, severity or 
outcome has been previously identified in the previously identified in nature, severity, or degree of incidence in the 
investigational plan or application  
 
Unanticipated Adverse Device Effect (UADE) – any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of subjects (21CFR812.3.s and ISO 14155). 
NOTE: The occurrence of a diagnostic or elective surgical procedure for a pre-existing condition, unless the 
condition becomes more severe or increases in frequency, would not be considered procedure or device-related. 
 
Adverse Device Effect (ADE) 
See Adverse Events. 
 
Case Report Form (CRF) 
Printed, optical or electronic document designed to record all of the protocol required information to be reported 
to the sponsor on each trial subject 
 
Confidentiality 
Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or a subject’s 
identity (GCP Consolidated Guidance). 
 
Ethics Committee (EC) / Institutional Review Board (IRB) 
Synonyms.  An independent body constituted of medical, scientific and nonscientific members, whose responsibility 
is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other 
things, reviewing, approving, and providing continuing review of trials, of protocols and amendments, and of the 
methods and material to be used in obtaining and documenting informed consent of the trial subjects (GCP 
Consolidated Guidance). 
 
Good Clinical Practice (GCP) 
An international quality standard for conducting clinical trials that is provided by International Conference on 
Harmonisation (ICH) to protect trial subjects rights, safety, and welfare, as well as provide integrity to the overall 
study data.  
 
Informed Consent 
The process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after 
having been informed of all aspects of the trial that are relevant to the subject’s decision to participate.  Informed 
consent is documented by means of a written, signed and dated consent form (GCP Consolidated Guidance). 
 
Informed Consent Form (ICF) 
A document disclosing the risks, benefits, and alternatives of a clinical trial and documents the subject’s voluntary 
willingness to participate in a clinical trial.  
 
Monitoring 
The act of overseeing the progress of a trial, and of ensuring that it is conducted, recorded and reported in 
accordance with the protocol, procedures and the applicable regulatory requirements. 
 
Patient and Observer Scar Assessment Scale (POSAS) 
The POSAS is a comprehensive scale that deals with the most commonly described scar characteristics from a patient 
and observers perspective 

 
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. 
Serious Adverse Device Effect (SADE)  
See Adverse Events. 
Serious Adverse Event (SAE) 
See Adverse Events. 
 
Source Data 
All information in original and identified records and certified copies of original records of clinical findings, 
observations, or other activities in a clinical investigation, necessary for the reconstruction and evaluation of the 
clinical investigation.  Source data are contained in source documents (ISO 14155 and GCP Consolidated Guidance). 
 
Source Documents  
Original documents, data and records (ISO 14155).   
NOTE:  This may be, for example, hospital records, laboratory notes, pharmacy dispensing records, copies or 
transcriptions certified after verification as being accurate copies, photographic negatives, radiographs, and 
records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical 
investigation. 
 
Unanticipated Adverse Device Effect (UADE) 
See Adverse Events. 
 

 
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Appendix A 
ZipLine Instructions for Use 

 
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