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

Breast Reconstruction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727025
• Other study ID #: CPHS 20069
• Status: Completed
• Phase: N/A
• Start date: July 2005
• Est. completion date: March 2008

Study information

• Verified date: May 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Elastosis
• Breast Hypertrophy
• Breast Reconstruction
• Hypertrophy

Intervention

Device:
• wound closure device (Steri-Strip™)
wound closure with steri-strip S

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar Quality at 6 Months Postoperative	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.	6 months
Primary	Time to Perform Wound Closure	Time from completion of deep dermal closure to complete closure of wound, either by steri-strip application or by subcuticular suture	intraoperatively
Secondary	Patient Postoperative Incisional Comfort	Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable	10 days