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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subcuticular absorbable polyglycolic acid (INSORB) staples | Active Comparator | Insorb absorbable staples are used for skin closure |
|
| subcuticular absorbable polyglecaprone suture (Monocryl) | Active Comparator | Monocryl absorbable staples are used for skin closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| absorbable subcuticular polyglycolic acid staples (INSORB) | Procedure | Insorb absorbable staples are used for skin closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| scar 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). | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Wound complications | wound complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence) | Week 6 |
| length of hospital stay | days spent in hospital |
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Inclusion Criteria:
Exclusion Criteria:
Females requiring Cesarean Section
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christina Tulbert | Contact | 336.716.2383 | Christina.Tulbert@Advocatehealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Joshua F Nitsche, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
All of the participant data collected during the trial and after deidentification
Beginning 9 months and ending 36 months following article publication
Investigators whose propose use of the data that has been approved by an Institutional Review Board
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| ID | Term |
|---|---|
| C095495 | glycolide E-caprolactone copolymer |
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trial comparing skin closure with absorbable subcuticular staples with subcuticular suture
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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.
|
| subcuticular, polyglecaprone suture (Monocryl) | Procedure | Monocryl absorbable staples are used for skin closure |
|
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| Week 6 |
| amount of in-hospital intravenous opiate analgesic use | amount of in-hospital intravenous opiate analgesic use | Week 6 |
| amount of in-hospital oral NSAID analgesic use | amount of in-hospital oral NSAID analgesic use | Week 6 |
| amount of in-hospital oral opiate analgesic use | amount of in-hospital oral opiate analgesic use | 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. | Week 6 |
| patient's overall satisfaction with cosmesis scores | 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 | Week 6 |