Status:
NOT_YET_RECRUITING
Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery
Lead Sponsor:
Inova Health Care Services
Conditions:
Pregnancy
Eligibility:
FEMALE
18-50 years
Phase:
NA
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...
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 subcutic...
Eligibility Criteria
Inclusion
- 18-50 years of age
- Women ≥ 24 weeks viable gestation
- Will be undergoing cesarean delivery
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT07167199
Start Date
February 1 2026
End Date
September 1 2027
Last Update
December 10 2025
Active Locations (1)
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1
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042