Tissue Adhesive vs. Sterile Strips After Cesarean Delivery

NCT02838017 | Terminated Results DMC

• 1 other identifier: EH16-095
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by Pfannenstiel skin incision. Currently, many Pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue A\\adhesive. Either sterile strips or tissue adhesive can be placed over the wound as a covering but it is unclear which may reduce wound complication rates. The hypothesis of this study is that tissue adhesive will result in a reduction in wound complication rates when compared to sterile strips. Previously published studies in non-obstetric populations have identified tissue adhesive as a potential intervention to reduce wound complications. The eligible population for this study will include women at NorthShore University HealthSystem Evanston Hospital and University of Chicago Hospital who will undergo primary or repeat cesarean delivery via Pfannenstiel skin incision. Women in the study will be randomized to receive either sterile strips or tissue adhesive. The primary outcome to be evaluated will be a composite of wound complication which will include drainage, cellulitis, hematoma, seroma and/or wound separation (partial or complete). Secondary endpoints to be investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference in operative times.

Conditions

Wound Complication; Complications; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Wound Complication

  Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation

  6-8 weeks from cesarean delivery

Secondary Outcomes (5)

• Number of Participants With Readmission for Wound Complication

  Within 8 weeks from cesarean delivery

• Satisfaction With Cesarean Scar

  6-8 weeks from cesarean delivery

• Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication

  Within 8 weeks of delivery

• Operative Time

  At time of delivery

• Number of Participants Requiring Antibiotic Treatment for Wound Complication

  Within 8 weeks of delivery

Study Arms (2)

Tissue Adhesive

EXPERIMENTAL

Tissue Adhesive will be placed over subcuticular suture closure.

Device: Tissue Adhesive

Steri-Strips

ACTIVE COMPARATOR

Sterile strips will be placed over subcuticular suture closure.

Device: Sterile strips

Interventions

Tissue Adhesive DEVICE

Also known as: Dermabond, Dermaflex, 2-octyl cyanoacrylate

Tissue Adhesive

Sterile strips DEVICE

Also known as: Steri-Strips

Steri-Strips

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing Pfannenstiel Cesarean delivery

You may not qualify if:

• Inability to provide informed consent in English
• Planned use of staples for skin closure
• Unavailability of research personnel to accomplish consent and randomization at the time of cesarean

Sponsors & Collaborators

• Endeavor Health: lead
• University of Chicago: collaborator

Study Sites (3)

University of Chicago

Chicago, Illinois, 60637, United States

Location

NorthShore Evanston Hospital

Evanston, Illinois, 60201, United States

Location

NorthShore Highland Park Hospital

Highland Park, Illinois, 60035, United States

Location

Related Publications (8)

• Souza EC, Fitaroni RB, Januzelli DM, Macruz HM, Camacho JC, Souza MR. Use of 2-octyl cyanoacrylate for skin closure of sternal incisions in cardiac surgery: observations of microbial barrier effects. Curr Med Res Opin. 2008 Jan;24(1):151-5. doi: 10.1185/030079908x253807.

  PMID: 18034920 BACKGROUND

• Mackeen AD, Packard RE, Ota E, Berghella V, Baxter JK. Timing of intravenous prophylactic antibiotics for preventing postpartum infectious morbidity in women undergoing cesarean delivery. Cochrane Database Syst Rev. 2014 Dec 5;2014(12):CD009516. doi: 10.1002/14651858.CD009516.pub2.

  PMID: 25479008 BACKGROUND

• Noorani A, Rabey N, Walsh SR, Davies RJ. Systematic review and meta-analysis of preoperative antisepsis with chlorhexidine versus povidone-iodine in clean-contaminated surgery. Br J Surg. 2010 Nov;97(11):1614-20. doi: 10.1002/bjs.7214.

  PMID: 20878942 BACKGROUND

• Stamilio DM, Scifres CM. Extreme obesity and postcesarean maternal complications. Obstet Gynecol. 2014 Aug;124(2 Pt 1):227-232. doi: 10.1097/AOG.0000000000000384.

  PMID: 25004353 BACKGROUND

• Tipton AM, Cohen SA, Chelmow D. Wound infection in the obese pregnant woman. Semin Perinatol. 2011 Dec;35(6):345-9. doi: 10.1053/j.semperi.2011.05.020.

  PMID: 22108085 BACKGROUND

• Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200.

  PMID: 28796687 BACKGROUND

• Daykan Y, Sharon-Weiner M, Pasternak Y, Tzadikevitch-Geffen K, Markovitch O, Sukenik-Halevy R, Biron-Shental T. Skin closure at cesarean delivery, glue vs subcuticular sutures: a randomized controlled trial. Am J Obstet Gynecol. 2017 Apr;216(4):406.e1-406.e5. doi: 10.1016/j.ajog.2017.01.009. Epub 2017 Jan 30.

  PMID: 28153666 BACKGROUND

• Braginsky L, Javellana M, Cleveland E, Elue R, Wang C, Boyle D, Plunkett BA. Tissue Adhesive Compared With Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Aug;134(2):295-301. doi: 10.1097/AOG.0000000000003367.

  PMID: 31306319 DERIVED

MeSH Terms

Interventions

Tissue Adhesives

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Lena Braginsky
• Organization: NorthShore University HealthSystem

lena.braginsky.mfm@gmail.com

2245952705

Study Officials

• Beth Plunkett, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

• Lena Braginsky, MD

  Endeavor Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Maternal & Fetal Medicine, Obstetrics & Gynecology

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 20, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 14, 2019
• Results First Posted: August 14, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available immediately after publication with no end date.
• Access Criteria: Investigators may request data by contacting lbraginsky@northshore.org

Locations

US (3)