Post-Operative Cesarean Section Cosmesis

NCT06412978 | Recruiting

• 1 other identifier: IRB00109639
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.

Conditions

Cesarean Delivery

Keywords

cosmetic improvement; surgical correction; Cosmesis

Outcome Measures

Primary Outcomes (1)

• scar cosmetic score

  Scars will be digitally photographed by study staff and scored by 2 independent judges (attending Obstetricians) according to the SCAR scale validated by Kantor with scores ranging from 0 (best) to 15 (worst).

  Week 6

Secondary Outcomes (7)

• Number of Wound complications

  Week 6

• length of hospital stay

  Week 6

• amount of in-hospital intravenous opiate analgesic use

  Week 6

• amount of in-hospital oral NSAID analgesic use

  Week 6

• amount of in-hospital oral opiate analgesic use

  Week 6

Study Arms (2)

subcuticular absorbable polyglycolic acid (INSORB) staples

ACTIVE COMPARATOR

Insorb absorbable staples are used for skin closure

Procedure: absorbable subcuticular polyglycolic acid staples (INSORB)

subcuticular absorbable polyglecaprone suture (Monocryl)

ACTIVE COMPARATOR

Monocryl absorbable staples are used for skin closure

Procedure: subcuticular, polyglecaprone suture (Monocryl)

Interventions

subcuticular, polyglecaprone suture (Monocryl) PROCEDURE

Monocryl absorbable staples are used for skin closure

Also known as: Monocryl

subcuticular absorbable polyglecaprone suture (Monocryl)

absorbable subcuticular polyglycolic acid staples (INSORB) PROCEDURE

Insorb absorbable staples are used for skin closure

Also known as: INSORB

subcuticular absorbable polyglycolic acid (INSORB) staples

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Females requiring Cesarean Section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-44
• Any race
• Any parity
• Scheduled cesarean section
• Neuraxial analgesia

You may not qualify if:

• Non-English Speaking
• Incarcerated
• Maternal Connective Tissue Disorder
• Systemic maternal steroid use
• Three prior cesarean deliveries
• Body Mass Index (BMI) \>40

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Interventions

glycolide E-caprolactone copolymer

Study Officials

• Joshua F Nitsche, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Tulbert

CONTACT

336.716.2383; Christina.Tulbert@Advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Scars will be digitally photographed by study staff and scored by 2 independent judges. The judges will be blinded to the closure method at time of scar evaluation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: trial comparing skin closure with absorbable subcuticular staples with subcuticular suture

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 14, 2024
• Study Start: September 5, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Investigators whose propose use of the data that has been approved by an Institutional Review Board

Locations

US (1)