Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Operating Time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
Reviewers of wound cosmetics during the post operative time will be blind to the intervention. However, surgeon at the time skin closure and patient will not be blinded to the intervention.
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18-50 years of age
- •Women ≥ 24 weeks viable gestation
- •Will be undergoing cesarean delivery
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.
Arms & Interventions
Suture wound closure
Absorbable sutures for closure of cesarean skin incision using Monocryl manufactured by Ethicon.
Intervention: Subcuticular monocryl suture manufactured by Ethicon (Device)
Absorbable staple wound closure
Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by Cooper Surgical.
Intervention: INSORB: subcuticular stapling device (Device)
Outcomes
Primary Outcomes
Operating Time
Time Frame: Start of surgery through end of skin closure in minutes
Total time for the procedure
Secondary Outcomes
- Use of Resources(Time of surgery through six weeks post partum)
- Post Operative Pain(5-10 days)
- Skin Closure Time in Minutes(Time of surgery through six weeks post partum)
- Wound Cosmesis(Time of surgery through six weeks post partum)
- Number of Adverse Events(Time of surgery through six weeks post partum)
- Number of Participants With Composite Wound Complication(Time of surgery through six weeks post partum)