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NCT06412978NARecruitingAccepts Healthy Volunteers

Post-Operative Cesarean Section Cosmesis

Wake Forest University Health Sciences

Start Date

9/5/2024

Completion Date

10/1/2026

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.

Detailed Description

Cesarean delivery is the most common surgical procedure performed in the United States, with over 1 million procedures performed per year. Based on recent Center for Disease Control (CDC) National Vital Statistics Report (2021) 32.1% of all births in the United States were via cesarean delivery. Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Absorbable staples, made from a combination of polylactic and polyglycolic acid, are a relatively new option for skin closure at the time of surgery. This study is a randomized trial that will investigates two cesarean skin closure techniques-subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples (INSORB)-to determine if one is associated with better scar cosmesis.

Eligibility Criteria

Age Range: 18 years to 44 years

Inclusion Criteria: * Age 18-44 * Any race * Any parity * Scheduled cesarean section * Neuraxial analgesia Exclusion Criteria: * Non-English Speaking * Incarcerated * Maternal Connective Tissue Disorder * Systemic maternal steroid use * Three prior cesarean deliveries * Body Mass Index (BMI) \>40

Interventions

PROCEDURE

absorbable subcuticular polyglycolic acid staples (INSORB)

PROCEDURE

subcuticular, polyglecaprone suture (Monocryl)

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Conditions

Cesarean Delivery

Locations

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States