NCT00727025

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Hypertrophy
• Abdominal Elastosis
• Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	wound closure device (Steri-Strip™)	wound closure with steri-strip S

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-01-01
• Completion: 2008-03-01
• First posted: 2008-08-01
• Last updated: 2023-10-31
• Results posted: 2013-05-20

Locations

1 site across 1 country: United States