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 — PROCEDURE
    Under the skin suture placed by hand
  • Subcuticular absorbable staple using Insorb device — DEVICE
    Under 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 closure
    Absorbable Moncryl sutures for closure of cesarean skin incision
  • Experimental: Absorbable staple wound closure
    Staples 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

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Fairfax Medical CampusFalls ChurchVirginia22042
Antonio Saad, MD
706-776-6040
Michelle L Cassidy, PhD, RN
(703) 776-4600
Antonio Saad, MD (PRINCIPAL_INVESTIGATOR)
Elle Murrin, MD (SUB_INVESTIGATOR)
Maggie Wong, MD (SUB_INVESTIGATOR)

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