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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00727025
Other study ID # CPHS 20069
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Intervention

Device:
wound closure device (Steri-Stripā„¢)
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
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