Post-Operative Cesarean Section Cosmesis

Wake Forest University (WFU)

Status: Enrolling

Conditions: Cesarean Delivery

Treatments: Procedure: subcuticular, polyglecaprone suture (Monocryl); Procedure: absorbable subcuticular polyglycolic acid staples (INSORB)

Study type: Interventional

Funder types: Other

Identifiers

NCT06412978

IRB00109639

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

subcuticular absorbable polyglycolic acid (INSORB) staples

Active Comparator group

Description:

Insorb absorbable staples are used for skin closure

Treatment:

Procedure: absorbable subcuticular polyglycolic acid staples (INSORB)

subcuticular absorbable polyglecaprone suture (Monocryl)

Active Comparator group

Description:

Monocryl absorbable staples are used for skin closure

Treatment:

Procedure: subcuticular, polyglecaprone suture (Monocryl)