Skin Glue Cesarean Study

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05903547
• Other study ID #: AAAT9584
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2023
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Columbia University
• Contact: Kristine Brown, MD
• Phone: 919-636-1735
• Email: kb3226[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: April 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Complication
• Wound

Intervention

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.

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

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center/NYP	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient scar satisfaction	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.	Up to 6 weeks post-surgery
Secondary	Incidence of surgical site infection (SSI)	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.	Up to 6 weeks post-surgery
Secondary	Skin closure time	The skin closure time will be assessed.	Intraoperative
Secondary	Operative time	The total operative time will be assessed.	Intraoperative