Tissue Adhesive vs. Sterile Strips After Cesarean Delivery (TASC)

July 22, 2019 updated by: Beth Plunkett, NorthShore University HealthSystem

Tissue Adhesive Compared to Sterile Strips After Cesarean Delivery: A Randomized Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

504

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
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Evanston, Illinois, United States, 60201
        • Northshore Evanston Hospital
      • Highland Park, Illinois, United States, 60035
        • NorthShore Highland Park Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women undergoing Pfannenstiel Cesarean delivery

Exclusion Criteria:

  • 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tissue Adhesive
Tissue Adhesive will be placed over subcuticular suture closure.
Device: Tissue Adhesive
Other Names:
  • Dermabond
  • Dermaflex
  • 2-octyl cyanoacrylate
Active Comparator: Steri-Strips
Sterile strips will be placed over subcuticular suture closure.
Device: Sterile strips
Other Names:
  • Steri-Strips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Wound Complication
Time Frame: 6-8 weeks from cesarean delivery
Wound drainage, Cellulitis, Abscess, Hematoma, Seroma or Separation
6-8 weeks from cesarean delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Readmission for Wound Complication
Time Frame: Within 8 weeks from cesarean delivery
Within 8 weeks from cesarean delivery
Satisfaction With Cesarean Scar
Time Frame: 6-8 weeks from cesarean delivery

The investigators will be using a modified validated Patient Scar Assessment Scale (PSAS) which assessed scar-related pain, itchiness, color, stiffness, irregularity and overall satisfaction with the scar. Each item on the PSAS has a 10-point scale, with 10 indicating the highest symptom severity or lowest satisfaction. The median score for each item was compared between groups.

Please see website in links section for more details on this assessment tool.
6-8 weeks from cesarean delivery
Number of Participants Who Required an Office or Emergency Department Visit for Wound Complication
Time Frame: Within 8 weeks of delivery
The investigators will review medical records to assess for ambulatory visits for wound complaints
Within 8 weeks of delivery
Operative Time
Time Frame: At time of delivery
The investigators will review operative records to assess operative time
At time of delivery
Number of Participants Requiring Antibiotic Treatment for Wound Complication
Time Frame: Within 8 weeks of delivery
The investigators will review medical records to assess for antibiotic prescriptions for wound complications
Within 8 weeks of delivery

Collaborators and Investigators

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

Sponsor

NorthShore University HealthSystem

Collaborators

University of Chicago

Investigators

  • Principal Investigator: Beth Plunkett, MD, Northshore University Healthsystem
  • Study Director: Lena Braginsky, MD, Northshore University Healthsystem

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

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

November 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH16-095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification, will be available upon request.

IPD Sharing Time Frame

Available immediately after publication with no end date.

IPD Sharing Access Criteria

Investigators may request data by contacting lbraginsky@northshore.org

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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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