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

Not Applicable

Completed

• Conditions: Abdominal Elastosis; Breast Hypertrophy; Breast Reconstruction

• Registration Number: NCT00727025
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2008-01
• Study Completion: 2008-03
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Results First Submitted: 2012-02-24
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-17
• Results First Posted: 2013-05-20
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Scar Quality at 6 Months Postoperative	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	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

Name	Time	Method
Patient Postoperative Incisional Comfort	10 days	Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States