Post-Operative Cosmesis and Skin Closure Methods After Cesarean Section
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- scar cosmetic score
Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18-44
- •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
Arms & Interventions
subcuticular absorbable polyglycolic acid (INSORB) staples
Insorb absorbable staples are used for skin closure
Intervention: absorbable subcuticular polyglycolic acid staples (INSORB) (Procedure)
subcuticular absorbable polyglecaprone suture (Monocryl)
Monocryl absorbable staples are used for skin closure
Intervention: subcuticular, polyglecaprone suture (Monocryl) (Procedure)
Outcomes
Primary Outcomes
scar cosmetic score
Time Frame: Week 6
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).
Secondary Outcomes
- amount of in-hospital oral opiate analgesic use(Week 6)
- Number of Wound complications(Week 6)
- length of hospital stay(Week 6)
- amount of in-hospital oral NSAID analgesic use(Week 6)
- patient rated subjective pain score(Week 6)
- patient's overall satisfaction with cosmesis scores(Week 6)
- amount of in-hospital intravenous opiate analgesic use(Week 6)