Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure

October 16, 2023 updated by: Dartmouth-Hitchcock Medical Center

Closing Linear Incisions in Plastic Surgery: A Randomized Clinical Trial Comparing a New Coaptive Film Device Versus Standard Subcuticular Sutures for Scar Quality, Patient Comfort, and Closure Time

Purpose: The aims of this randomized clinical trial are:

  1. to assess scar quality from the patient and surgeon perspectives
  2. to assess patient comfort in the days immediately following surgery
  3. to assess the time taken to complete closure in the operating room.
  4. the financial benefit or cost for the institution of using Steri Strip S will also be estimated.

Two closure methods will be compared, a new coaptive film device (Steri Strip S) versus standard subcuticular sutures. The linear incisions will include the standard incision segments utilized for an inverted-T closure for bilateral breast reduction and the transabdominal incision segments utilized for abdominoplasty or TRAM flap harvest.

Our hypothesis is that incisions segments closed with Steri Strip S compared to standard subcuticular closure, will yield scars of better cosmetic quality, in shorter time to closure, with novice and expert surgeons, for both bilateral breast reduction and abdominoplasty surgical procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

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
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients are eligible for enrollment if they agree to provide informed consent, are at least 18 years of age, in generally good health, and available for follow-up in the 5-7 month time frame.

Exclusion Criteria:

  • Women known to be pregnant, minors, patients potentially incompetent to provide informed consent or complete the surveys described in our protocol will be excluded from this trial.

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: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scar Quality at 6 Months Postoperative
Time Frame: 6 months
Patients used a rating scale with range of 1-9 with 1 being the best scar and 9 being the worst scar. Patients had photos of scars within this range to anchor their choices.
6 months
Time to Perform Wound Closure
Time Frame: intraoperatively
Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture
intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Postoperative Incisional Comfort
Time Frame: 10 days
Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable
10 days

Collaborators and Investigators

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

Sponsor

Dartmouth-Hitchcock Medical Center

Investigators

  • Principal Investigator: Carolyn L Kerrigan, MD, Dartmouth-Hitchcock Medical Center

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

July 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

July 30, 2008

First Submitted That Met QC Criteria

July 31, 2008

First Posted (Estimated)

August 1, 2008

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPHS 20069

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.

Clinical Trials on Breast Reconstruction

Clinical Trials on wound closure device (Steri-Strip™)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe