Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

NCT07167199 | Not Yet Recruiting FDA Device

• 1 other identifier: INOVA-2024-333
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

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

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Operating time

  Total time for the procedure

  Time from the start of surgery through end of skin closure up to 8 hours

Secondary Outcomes (2)

• Wound Cosmesis

  Up to six weeks post partum

• Post Operative Pain

  up to 3 days post-operatively

Other Outcomes (3)

• Number of Adverse Events

  Up to 6 weeks post-partum

• Number of participants with any unscheduled postpartum visit

  up to 30 days post-operatively

• Skin Closure Time in Minutes

  Time from start of skin closure to end of skin closure up to 2 hours

Study Arms (2)

Suture wound closure

ACTIVE COMPARATOR

Absorbable Moncryl sutures for closure of cesarean skin incision

Procedure: Subcuticular monocryl suture

Absorbable staple wound closure

EXPERIMENTAL

Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by CooperSurgical.

Device: Subcuticular absorbable staple using Insorb device

Interventions

Subcuticular monocryl suture PROCEDURE

Under the skin suture placed by hand

Suture wound closure

Subcuticular absorbable staple using Insorb device DEVICE

Under the skin stapling device that delivers absorbable staples

Absorbable staple wound closure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Women ≥ 24 weeks viable gestation
• Will be undergoing cesarean delivery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Study Officials

• Antonio Saad, MD

  Inova Fairfax Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Saad, MD

CONTACT

(703) 779-6040; antonio.saad@inova.org

Michelle L Cassidy, PhD, RN

CONTACT

(703) 776-4600; michelle.cassidy@inova.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 11, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)