A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study

April 4, 2026 updated by: Russell Miller, Columbia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center/NYP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dermabond Prineo Group
At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.
Device: Dermabond Prineo
For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.
Placebo Comparator: Suture Group
At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Other: Suture
For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at 6-weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Closure Time
Time Frame: Intraoperative
The skin closure time will be assessed.
Intraoperative
Operative Time
Time Frame: Intraoperative
The total operative time will be assessed.
Intraoperative
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.
Assessed during delivery hospitalization and at 6-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Russell Miller, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Actual)

December 6, 2024

Study Completion (Actual)

February 5, 2025

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT9584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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