A Skin Glue Versus Subcuticular Suture for Cesarean Closure Study

NCT05903547 | Completed Results FDA Device

• 1 other identifier: AAAT9584
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section; Complication; Wound

Keywords

Complications; Wound; Hematoma; Surgical Incision

Outcome Measures

Primary Outcomes (1)

• Patient Scar Satisfaction Scale Score

  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 Outcomes (3)

• Incidence of Surgical Site Infection (SSI)

  Assessed during delivery hospitalization and at 6-week follow-up

• Skin Closure Time

  Intraoperative

• Operative Time

  Intraoperative

Study Arms (2)

Dermabond Prineo Group

ACTIVE COMPARATOR

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

Suture Group

PLACEBO COMPARATOR

At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.

Other: Suture

Interventions

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.

Dermabond Prineo Group

Suture OTHER

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

Suture Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center/NYP

New York, New York, 10032, United States

Location

Related Publications (4)

• Goto S, Sakamoto T, Ganeko R, Hida K, Furukawa TA, Sakai Y. Subcuticular sutures for skin closure in non-obstetric surgery. Cochrane Database Syst Rev. 2020 Apr 9;4(4):CD012124. doi: 10.1002/14651858.CD012124.pub2.

  PMID: 32271475 BACKGROUND

• Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJ. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD004287. doi: 10.1002/14651858.CD004287.pub4.

  PMID: 25431843 BACKGROUND

• van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.

  PMID: 16079683 BACKGROUND

• Fleisher J, Khalifeh A, Pettker C, Berghella V, Dabbish N, Mackeen AD. Patient satisfaction and cosmetic outcome in a randomized study of cesarean skin closure. J Matern Fetal Neonatal Med. 2019 Nov;32(22):3830-3835. doi: 10.1080/14767058.2018.1474870. Epub 2018 May 24.

  PMID: 29739243 BACKGROUND

Related Links

• Dermabond Prineo

MeSH Terms

Conditions

Wounds and Injuries; Hematoma; Surgical Wound

Interventions

Sutures

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Russell Miller, MD
• Organization: Columbia University

rsm20@cumc.columbia.edu

212-305-6293

Study Officials

• Russell Miller, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women undergoing cesarean delivery will be recruited and randomized to skin closure with either the Dermabond Prineo system or standard subcuticular suture.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: August 23, 2023
• Primary Completion: December 6, 2024
• Study Completion: February 5, 2025
• Last Updated: February 25, 2026
• Results First Posted: January 29, 2026

Record last verified: 2026-02

Locations

US (1)