N/A
N=74
Randomized Controlled Trial of Subcuticular Skin Closure Versus Steri-strip S Closure
Breast Hypertrophy · Abdominal Elastosis · Breast Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT00727025 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Scar Quality at 6 Months Postoperative — 3.8; 2.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- wound closure device (Steri-Strip™) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Scar Quality at 6 Months Postoperative |
3.8; 2.6 | — |
| PRIMARY Time to Perform Wound Closure |
2.0; 4.6 | — |
| SECONDARY Patient Postoperative Incisional Comfort |
5.8; 6.9 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00727025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.