Zip Incision Approximation vs. Suture for C-Section

Study Overview
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Brief Summary
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The study will evaluate the ZipLine Medical Surgical Skin Closure device (Zip)versus sutures when utilized for skin layer closure during wound closure of Cesarean Section Procedure.

Detailed Description
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Cesarean-section birth is a very invasive surgical procedure. While the desired outcome focuses primarily on the successful delivery of a healthy baby and maintenance of the mother's health, the surgery involves a complex surgical closure process, starting with the uterus, and progressing through several layers of traditionally suture closure in several tissue planes. A successful closure results in no surgical site complications, with good patient comfort and a minimal scar being a desired outcome. Conventional skin closure methods such as sutures are effective but have drawbacks. It has been suggested that the ideal method of wound / incision closure should be: fast non-traumatic minimally or non-invasive associated with a low incidence of adverse events such as dehiscence and infection yielding acceptable cosmetic results ZipLine Medical, Inc. is a Campbell, California-based company that 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. In the USA, the device has been classified by the FDA as a Class I, 510(k) Exempt device and began commercial use in the USA in April 2013. The ZipLine Device has been clinically demonstrated benefits include (references included later in this document): Closure speed faster/superior to (and less variable compared to) sutures Suture-like cosmetic outcome Reduction in post-surgical care costs Fewer closure-related wound issues Greater patient satisfaction

Official Title
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A Prospective, Non-blinded, Randomized Controlled Post-market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device Versus Sutures for Skin Closure in Subjects Who Undergo a Cesarean Section Procedure.

Conditions
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C.Surgical Procedure; Dehiscence, Cesarean Section

Intervention / Treatment
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* Device: Zip Surgical Skin Closure Device
* Other: Conventional Sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age and older Primary C-section Patients willing and able to complete study protocol Exclusion Criteria: Known bleeding disorder not caused by medication Known personal or family history of keloid formation or scar hypertrophy Known allergy or hypersensitivity to non-latex skin adhesives Atrophic skin deemed clinically prone to blistering Any skin disorder affecting wound healing Any other condition that in the opinion of the investigator would make a particular subject unsuitable for this study Emergent C-Section Non-primary C-Section

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zip Closure Device<br>The Zip device is a non-invasive, single use, sterile medical device for closure of the skin layer for surgical incisions or laceration repair. | Device: Zip Surgical Skin Closure Device<br>* The Zip Surgical Skin Closure Device will be used for surgical wound closure in C-Section Surgery<br>* Other names: Zip;|
| Active Comparator: Conventional Sutures<br>Conventional subdermal (subcuticular) absorbable sutures | Other: Conventional Sutures<br>* Conventional Sutures will be used for surgical wound closure in C-Section Surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Procedure Closure | Upon closure of the Cesarean incision - Zip or Suture touches skin to close incision | Procedure Closure - Zip or Suture touches skin until skin is closed | 
| Cosmetic Visual Analogue Scale (CVAS) | 100-mm Cosmetic Visual Analogue Scale (CVAS) for incision appearance | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon Closure Method Satisfaction | Satisfaction with closure method, scar appearance | Procedure, 3-5 days, 3 months | 
| Patient Closure Method Satisfaction | Satisfaction with closure method, scar appearance | 3-5 days, 14 days, 3 months | 
| Patient Pain and Discomfort by Subject Questionnaire | Pain associated with the closure method and level of discomfort during use will be asked by questionnaire | 3-5 days, 14 days, 3 months | 
| Incidence and severity of Adverse Events | The incidence and severity of adverse events (AE) associated with Zip device and control will be evaluated | Procedure, 3-5 days, 14 days, 3 months |