Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery
Part of paid clinical trials in Falls Church, Virginia.
- Sponsor
- Inova Health Care Services
- Study ID
- NCT07167199
- Status
- Not Yet Recruiting
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Conditions
- Pregnancy
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- Subcuticular monocryl suture — PROCEDUREUnder the skin suture placed by hand
- Subcuticular absorbable staple using Insorb device — DEVICEUnder the skin stapling device that delivers absorbable staples
Study Details
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
Key Dates
- Start date
- Aug 1, 2026
- Status verified
- Dec 2025
- Primary completion
- Sep 1, 2027
- Completion
- Sep 1, 2027
Study Design
- Enrollment
- 237 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Active Comparator: Suture wound closureAbsorbable Moncryl sutures for closure of cesarean skin incision
- Experimental: Absorbable staple wound closureStaples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by CooperSurgical.
Primary Outcome Measure
Operating time [ Time Frame: Time from the start of surgery through end of skin closure up to 8 hours ]
Central Contacts
- Antonio Saad, MD(703) 779-6040
- Michelle L Cassidy, PhD, RN(703) 776-4600
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | Antonio Saad, MD (PRINCIPAL_INVESTIGATOR) Elle Murrin, MD (SUB_INVESTIGATOR) Maggie Wong, MD (SUB_INVESTIGATOR) |
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