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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00727025
First received: July 30, 2008
Last updated: May 17, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Breast Hypertrophy
Abdominal Elastosis
Breast Reconstruction
 Device: wound closure device (Steri-Strip™)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Scar Quality at 6 Months Postoperative [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Time to Perform Wound Closure [ Time Frame: intraoperatively ] [ Designated as safety issue: No ]
    Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture


Secondary Outcome Measures:
  • Patient Postoperative Incisional Comfort [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable


Enrollment: 51
Study Start Date: July 2005
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: wound closure device (Steri-Strip™)
    wound closure with steri-strip S
    Other Name: 3M™ Steri-Strip™ S Surgical Skin Closure
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727025

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Carolyn L Kerrigan, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided by Dartmouth-Hitchcock Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00727025     History of Changes
Other Study ID Numbers: CPHS 20069
Study First Received: July 30, 2008
Results First Received: February 24, 2012
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
skin closure devices
linear scars

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013