Clinical trial NCT02915952: Zip Incision Approximation vs. Suture for C-Section
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: C.Surgical Procedure; Dehiscence, Cesarean Section
Lead sponsor: ZipLine Medical Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Time of Procedure Closure
timeFrame: Procedure Closure - Zip or Suture touches skin until skin is closed
measure: Cosmetic Visual Analogue Scale (CVAS)
timeFrame: 3 months
Secondary outcomes:
measure: Surgeon Closure Method Satisfaction
timeFrame: Procedure, 3-5 days, 3 months
measure: Patient Closure Method Satisfaction
timeFrame: 3-5 days, 14 days, 3 months
measure: Patient Pain and Discomfort by Subject Questionnaire
timeFrame: 3-5 days, 14 days, 3 months
measure: Incidence and severity of Adverse Events
timeFrame: Procedure, 3-5 days, 14 days, 3 months
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Elias Castel, MD
role: PRINCIPAL_INVESTIGATOR
References: