Cesarean Delivery
Conditions
Keywords
cosmetic improvement, surgical correction, Cosmesis
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.
Interventions
PROCEDUREabsorbable subcuticular polyglycolic acid staples (INSORB)
Insorb absorbable staples are used for skin closure
PROCEDUREsubcuticular, polyglecaprone suture (Monocryl)
Monocryl absorbable staples are used for skin closure
Sponsors
Wake Forest University Health Sciences
Study design
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.
Intervention model description
trial comparing skin closure with absorbable subcuticular staples with subcuticular suture
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 intravenous opiate analgesic use | Week 6 | amount of in-hospital intravenous opiate analgesic use |
| amount of in-hospital oral NSAID analgesic use | Week 6 | amount of in-hospital oral NSAID analgesic use |
| amount of in-hospital oral opiate analgesic use | Week 6 | amount of in-hospital oral opiate 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 |
Countries
United States
Contacts
CONTACTChristina Tulbert
PRINCIPAL_INVESTIGATORJoshua F Nitsche, MD
Wake Forest University Health Sciences
Outcome results
None listed