C.Surgical Procedure; Dehiscence, Cesarean Section
Conditions
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
Interventions
The Zip Surgical Skin Closure Device will be used for surgical wound closure in C-Section Surgery
OTHERConventional Sutures
Conventional Sutures will be used for surgical wound closure in C-Section Surgery
Sponsors
ZipLine Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Cosmetic Visual Analogue Scale (CVAS) | 3 months | 100-mm Cosmetic Visual Analogue Scale (CVAS) for incision appearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Closure Method Satisfaction | Procedure, 3-5 days, 3 months | Satisfaction with closure method, scar appearance |
| Patient Closure Method Satisfaction | 3-5 days, 14 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 |
Countries
Israel
Contacts
Primary ContactWendy M Winters
Backup ContactEric Storne
Outcome results
None listed