Post-Operative Cesarean Section Cosmesis
- Conditions
- Cesarean Delivery
- Interventions
- Procedure: absorbable subcuticular polyglycolic acid staples (INSORB)Procedure: subcuticular, polyglecaprone suture (Monocryl)
- Registration Number
- NCT06412978
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 52
- Age 18-44
- Any race
- Any parity
- Scheduled cesarean section
- Neuraxial analgesia
- Non-English Speaking
- Incarcerated
- Maternal Connective Tissue Disorder
- Systemic maternal steroid use
- Three prior cesarean deliveries
- Body Mass Index (BMI) >40
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description subcuticular absorbable polyglycolic acid (INSORB) staples absorbable subcuticular polyglycolic acid staples (INSORB) Insorb absorbable staples are used for skin closure subcuticular absorbable polyglecaprone suture (Monocryl) subcuticular, polyglecaprone suture (Monocryl) Monocryl absorbable staples are used for skin closure
- Primary Outcome Measures
Name Time Method scar cosmetic score 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 Outcome Measures
Name Time Method amount of in-hospital oral opiate analgesic use Week 6 amount of in-hospital oral opiate analgesic use
Number of Wound complications Week 6 wound complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence)
length of hospital stay Week 6 days spent in hospital
amount of in-hospital oral NSAID analgesic use Week 6 amount of in-hospital oral NSAID analgesic use
patient rated subjective pain score Week 6 patient rated subjective pain score (0-10 based on visual analog scale) - 100-mm visual analog scale (VAS) ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
patient's overall satisfaction with cosmesis scores Week 6 The Patient and Observer Scar Assessment Scale (POSASA) All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). Higher scores meaning more scarring
amount of in-hospital intravenous opiate analgesic use Week 6 amount of in-hospital intravenous opiate analgesic use
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States