Skip to main content
OpenTrials
Completed

NCT Number: NCT05903547

A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study

The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cesarean Section Complication Hematoma Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Surgical Wound Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center/NYP

New York, 10032, United States

About this study

The purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. Patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the Dermabond Prineo skin adhesive system versus standard subcuticular suture. Dermabond Prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. In addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women age 18 years or older
  • All women scheduled for primary or repeat cesarean deliveries
  • All women undergoing intrapartum or antepartum cesarean delivery
  • Pfannenstiel skin incision
  • Birth of a live infant at time of cesarean delivery

Exclusion criteria

  • Vertical skin incision
  • Cesarean hysterectomy
  • Emergency or stat cesarean delivery excluding standard preoperative preparation measures (i.e., use of Chlorhexidine skin prep, vaginal prep, etc)
  • Intrapartum stillbirth
  • Planned postpartum follow up at another facility
  • Contraindications to routine postpartum pain medications
  • Adhesive or tape allergy

Treatment and study plan

DERMABOND PRINEO

Device

For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.

Suture

Other

For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.

Primary outcomes

  1. Patient Scar Satisfaction Scale Score

    Time frame: Assessed at 6-weeks postpartum

    The patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction.

Secondary outcomes

  1. Incidence of Surgical Site Infection (SSI)

    Time frame: Assessed during delivery hospitalization and at 6-week follow-up

    A composite of surgical site infection (SSI) will be assessed. This composite will include superficial and deep SSI, endometritis, wound separation from any cause, and/or fascial dehiscence.

  2. Skin Closure Time

    Time frame: Intraoperative

    The skin closure time will be assessed.

  3. Operative Time

    Time frame: Intraoperative

    The total operative time will be assessed.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Glue Versus Subcuticular Suture for Cesarean Closure: a Randomized Control Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jun 15, 2023
Registry last updated
Apr 7, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.