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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.
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:
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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zip Closure Device | Active Comparator | The Zip device is a non-invasive, single use, sterile medical device for closure of the skin layer for surgical incisions or laceration repair. |
|
| Conventional Sutures | Active Comparator | Conventional subdermal (subcuticular) absorbable sutures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zip Surgical Skin Closure Device | Device | The Zip Surgical Skin Closure Device will be used for surgical wound closure in C-Section Surgery |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy M Winters | Contact | 408-506-1866 | wwinters0@gmail.com | |
| Eric Storne | Contact | 888-326-8999 | estorne@ziplinemedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Elias Castel, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Tel Litwinsky | 52621 | Israel |
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| Conventional Sutures | Other | Conventional Sutures will be used for surgical wound closure in C-Section Surgery |
|
| 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 |