Zip Incision Approximation vs. Suture for C-Section
- Conditions
- C.Surgical Procedure; Dehiscence, Cesarean Section
- Interventions
- Other: Conventional SuturesDevice: Zip Surgical Skin Closure Device
- Registration Number
- NCT02915952
- Lead Sponsor
- ZipLine Medical Inc.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Patients 18 years of age and older
- Primary C-section
- Patients willing and able to complete study protocol
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional Sutures Conventional Sutures Conventional subdermal (subcuticular) absorbable sutures Zip Closure Device Zip Surgical Skin 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.
- Primary Outcome Measures
Name Time Method Cosmetic Visual Analogue Scale (CVAS) 3 months 100-mm Cosmetic Visual Analogue Scale (CVAS) for incision appearance
Time of Procedure Closure Procedure Closure - Zip or Suture touches skin until skin is closed Upon closure of the Cesarean incision - Zip or Suture touches skin to close incision
- Secondary Outcome Measures
Name Time Method Surgeon Closure Method Satisfaction Procedure, 3-5 days, 3 months Satisfaction with closure method, scar appearance
Patient Pain and Discomfort by Subject Questionnaire 3-5 days, 14 days, 3 months Pain associated with the closure method and level of discomfort during use will be asked by questionnaire
Incidence and severity of Adverse Events Procedure, 3-5 days, 14 days, 3 months The incidence and severity of adverse events (AE) associated with Zip device and control will be evaluated
Patient Closure Method Satisfaction 3-5 days, 14 days, 3 months Satisfaction with closure method, scar appearance
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Tel Hashomer, Israel