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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

July 30, 2008
August 1, 2008
February 24, 2012
May 20, 2013
May 20, 2013
July 2005
January 2008   (Final data collection date for primary outcome measure)
  • 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.
  • 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
Scar Quality at 6 Months Postoperative [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00727025 on ClinicalTrials.gov Archive Site
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
  • Time for incision closure
  • Patient Postoperative Incisional Comfort [ Time Frame: 10 days ]
Not Provided
Not Provided
 
Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure
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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
  • Breast Hypertrophy
  • Abdominal Elastosis
  • Breast Reconstruction
Device: wound closure device (Steri-Strip™)
wound closure with steri-strip S
Other Name: 3M™ Steri-Strip™ S Surgical Skin Closure
Not Provided
Kerrigan CL, Homa K. Evaluation of a new wound closure device for linear surgical incisions: 3M Steri-Strip S Surgical Skin Closure versus subcuticular closure. Plast Reconstr Surg. 2010 Jan;125(1):186-94. doi: 10.1097/PRS.0b013e3181c2a492.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
Same as current
March 2008
January 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00727025
CPHS 20069
Yes
Not Provided
Not Provided
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Not Provided
Principal Investigator: Carolyn L Kerrigan, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP