Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

Not Applicable

Terminated

Brief Summary: Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.

Detailed Description: This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Patient unwilling or unable to provide consent.
No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery.
Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other
Decision not to have skin closure (e.g. secondary wound closure, mesh closure)
Current skin infection
Coagulopathy
High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery)
Incarcerated individuals
Intraamniotic infection
Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.

Arm && Interventions

Group	Intervention	Description
Suture wound closure	Subcuticular monocryl suture manufactured by Ethicon	Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon.

Primary Outcome Measures

Name	Time	Method
Operating Time	Start of surgery through end of skin closure in minutes	Total time for the procedure

Secondary Outcome Measures

Name	Time	Method
Use of Resources	Time of surgery through six weeks post partum	Postpartum clinic or emergency room visit within 30 days of delivery, need for imaging or other invasive procedures
Post Operative Pain	5-10 days	Analog pain scale ranging from 0-10. This is a standard question that nurses as during the post partum period while in the hospital and clinic/nursing visits. The numerical score will be recorded from the patient's chart. A score of 0 means no pain, and 10 means the worst pain.
Skin Closure Time in Minutes	Time of surgery through six weeks post partum	The average of minutes it takes for closure of the skin at time of surgery through weeks post partum.
Wound Cosmesis	Time of surgery through six weeks post partum	A digital photograph of the incision will be obtained on wound check visit POD 5-10 days. Each photograph will be evaluated by independent blinded research staff using the Stony Brook Scar Evaluation Scale.These scores are totaled to obtain the final score. The Stony Brook Scar Evaluation will score the scar from 0-5 where 5 shows significant healing.
Number of Adverse Events	Time of surgery through six weeks post partum	Allergic reactions: anaphylaxis, angioedema, skin rashes, including Stevens Johnson and Toxic Epidermal Necrolysis
Number of Participants With Composite Wound Complication	Time of surgery through six weeks post partum	Hematoma, seroma, dehiscence, breakdown of wound, wound infection, endometritis, sepsis, post part fevers