Skin Glue Cesarean Study

Not Applicable

Active, not recruiting

• Conditions: Complication; Wound; Cesarean Section
• Interventions: Other: Suture; Device: Dermabond Prineo

• Registration Number: NCT05903547
• Lead Sponsor: Columbia University

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.

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 Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Study Start: 2023-08-23
• Primary Completion: 2024-12-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture Group	Suture	At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture.
Dermabond Prineo Group	Dermabond Prineo	At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system.

Primary Outcome Measures

Name	Time	Method
Patient scar satisfaction	Up to 6 weeks post-surgery	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 Outcome Measures

Name	Time	Method
Incidence of surgical site infection (SSI)	Up to 6 weeks post-surgery	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.
Operative time	Intraoperative	The total operative time will be assessed.
Skin closure time	Intraoperative	The skin closure time will be assessed.

Trial Locations

Locations (1)

Columbia University Irving Medical Center/NYP; 🇺🇸 New York, New York, United States