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
Purpose: The aims of this randomized clinical trial are:
- to assess scar quality from the patient and surgeon perspectives
- to assess patient comfort in the days immediately following surgery
- to assess the time taken to complete closure in the operating room.
- 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|
|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|
Device: wound closure device (Steri-Strip™)
- 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
- 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
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
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Carolyn L Kerrigan, MD||Dartmouth-Hitchcock Medical Center|