Recruiting

Surgical Techniques

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06412978

Conditions

Cesarean Delivery

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

Interventions

absorbable subcuticular polyglycolic acid staples (INSORB)

subcuticular, polyglecaprone suture (Monocryl)

Study Details

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.

Conditions

Cesarean Delivery

Study ID

NCT06412978

Start date

Sep 5, 2024

Status verified date

Mar, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

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

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: subcuticular absorbable polyglycolic acid (INSORB) staples

Insorb absorbable staples are used for skin closure

active comparator: subcuticular absorbable polyglecaprone suture (Monocryl)

Monocryl absorbable staples are used for skin closure

Interventions

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

Primary outcome measure

  • scar cosmetic score [ Time Frame: Week 6 ]

Central Contacts and Locations

Central contacts

Christina Tulbert

336.716.2383Christina.Tulbert@Advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Christina Tulbert

336-716-2383Christina.Tulbert@Advocatehealth.org

Principal Investigator:

Joshua F Nitsche, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • cosmetic improvement
  • surgical correction
  • Cosmesis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-03-16.