Post-Operative Cesarean Section Cosmesis

Cesarean Delivery Clinical Trial

Official title:

Post-Operative Cosmesis and Skin Closure Methods After Cesarean Section

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412978
• Other study ID #: IRB00109639
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Christina Tulbert
• Phone: 336.716.2383
• Email: ctulbert[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Delivery

Intervention

Procedure:
• absorbable subcuticular polyglycolic acid staples (INSORB)
Insorb absorbable staples are used for skin closure
• subcuticular, polyglecaprone suture (Monocryl)
Monocryl absorbable staples are used for skin closure

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Number of Wound complications	wound complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence)	Week 6
Secondary	length of hospital stay	days spent in hospital	Week 6
Secondary	amount of in-hospital intravenous opiate analgesic use	amount of in-hospital intravenous opiate analgesic use	Week 6
Secondary	amount of in-hospital oral NSAID analgesic use	amount of in-hospital oral NSAID analgesic use	Week 6
Secondary	amount of in-hospital oral opiate analgesic use	amount of in-hospital oral opiate analgesic use	Week 6
Secondary	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
Secondary	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