Zip Incision Approximation vs. Suture for C-Section

C.Surgical Procedure; Dehiscence, Cesarean Section Clinical Trial

— ZIPS-C  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02915952
• Other study ID #: ZipsC-006
• Status: Recruiting
• Phase: N/A
• First received: September 16, 2016
• Last updated: August 2, 2017
• Start date: August 2016
• Est. completion date: January 2018

Study information

• Verified date: August 2017
• Source: ZipLine Medical Inc.
• Contact: Wendy M Winters
• Phone: 408-506-1866
• Email: wwinters0[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• C.Surgical Procedure; Dehiscence, Cesarean Section

Intervention

Device:
• Zip Surgical Skin Closure Device
The Zip Surgical Skin Closure Device will be used for surgical wound closure in C-Section Surgery

Other:
• Conventional Sutures
Conventional Sutures will be used for surgical wound closure in C-Section Surgery

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
ZipLine Medical Inc.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cosmetic Visual Analogue Scale (CVAS)	100-mm Cosmetic Visual Analogue Scale (CVAS) for incision appearance	3 months
Secondary	Surgeon Closure Method Satisfaction	Satisfaction with closure method, scar appearance	Procedure, 3-5 days, 3 months
Secondary	Patient Closure Method Satisfaction	Satisfaction with closure method, scar appearance	3-5 days, 14 days, 3 months
Secondary	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
Secondary	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