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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
52
Insorb absorbable staples are used for skin closure
Monocryl absorbable staples are used for skin closure
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
RECRUITINGscar cosmetic score
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).
Time frame: Week 6
Number of Wound complications
wound complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence)
Time frame: Week 6
length of hospital stay
days spent in hospital
Time frame: Week 6
amount of in-hospital intravenous opiate analgesic use
amount of in-hospital intravenous opiate analgesic use
Time frame: Week 6
amount of in-hospital oral NSAID analgesic use
amount of in-hospital oral NSAID analgesic use
Time frame: Week 6
amount of in-hospital oral opiate analgesic use
amount of in-hospital oral opiate analgesic use
Time frame: Week 6
patient rated subjective pain score
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.
Time frame: Week 6
patient's overall satisfaction with cosmesis scores
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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
Time frame: Week 6