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NCT Number: NCT06412978

Post-Operative Cesarean Section Cosmesis

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.

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Key information

Conditions

Cesarean Delivery

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Christina Tulbert

CONTACT

[email protected]

336-716-2383

Joshua F Nitsche, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

absorbable subcuticular polyglycolic acid staples (INSORB)

Procedure

Insorb absorbable staples are used for skin closure

Other names: INSORB

subcuticular, polyglecaprone suture (Monocryl)

Procedure

Monocryl absorbable staples are used for skin closure

Other names: Monocryl

Primary outcomes

  1. scar cosmetic score

    Time frame: 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 outcomes

  1. Number of Wound complications

    Time frame: Week 6

    wound complications (infection, dehiscence, seroma, hematoma, skin and fat necrosis, skin and fascial dehiscence)

  2. length of hospital stay

    Time frame: Week 6

    days spent in hospital

  3. amount of in-hospital intravenous opiate analgesic use

    Time frame: Week 6

    amount of in-hospital intravenous opiate analgesic use

  4. amount of in-hospital oral NSAID analgesic use

    Time frame: Week 6

    amount of in-hospital oral NSAID analgesic use

  5. amount of in-hospital oral opiate analgesic use

    Time frame: Week 6

    amount of in-hospital oral opiate analgesic use

  6. patient rated subjective pain score

    Time frame: 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.

  7. patient's overall satisfaction with cosmesis scores

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Tulbert

CONTACT

[email protected]

336.716.2383

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Post-Operative Cosmesis and Skin Closure Methods After Cesarean Section

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 14, 2024
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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