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

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ClinicalTrials.gov Identifier: NCT00727025
Recruitment Status : Completed
First Posted : August 1, 2008
Results First Posted : May 20, 2013
Last Update Posted : May 20, 2013
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Hypertrophy Abdominal Elastosis Breast Reconstruction Device: wound closure device (Steri-Strip™) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Device: wound closure device (Steri-Strip™)
    wound closure with steri-strip S
    Other Name: 3M™ Steri-Strip™ S Surgical Skin Closure


Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 1, 2008    Key Record Dates
Results First Posted: May 20, 2013
Last Update Posted: May 20, 2013
Last Verified: May 2013

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

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical