Zip Incision Approximation vs. Suture for C-Section (ZIPS-C)

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.

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.

Study Overview

• Status: Unknown
• Conditions: C.Surgical Procedure; Dehiscence, Cesarean Section
• Intervention / Treatment: Device: Zip Surgical Skin Closure Device; Other: Conventional Sutures

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Hashomer, Israel, 52621
    • Recruiting
    • Sheba Medical Center
    • Contact: Elias Castel, MD; Email: eliasary@gmail.com
    • Principal Investigator: Elias Castel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients 18 years of age and older
2. Primary C-section
3. Patients willing and able to complete study protocol

Exclusion Criteria:

1. Known bleeding disorder not caused by medication
2. Known personal or family history of keloid formation or scar hypertrophy
3. Known allergy or hypersensitivity to non-latex skin adhesives
4. Atrophic skin deemed clinically prone to blistering
5. Any skin disorder affecting wound healing
6. Any other condition that in the opinion of the investigator would make a particular subject unsuitable for this study
7. Emergent C-Section
8. Non-primary C-Section

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Zip Closure Device; 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; The Zip Surgical Skin Closure Device will be used for surgical wound closure in C-Section Surgery; Other Names: Zip
Active Comparator: Conventional Sutures; Conventional subdermal (subcuticular) absorbable sutures	Other: Conventional Sutures; Conventional Sutures will be used for surgical wound closure in C-Section Surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ZipLine Medical Inc.
• Investigators: Principal Investigator: Elias Castel, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 24, 2016
• First Posted (Estimate): September 27, 2016

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ZipsC-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No