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

Study Overview
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Brief Summary
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Purpose: The aims of this randomized clinical trial are: to assess scar quality from the patient and surgeon perspectives to assess patient comfort in the days immediately following surgery to assess the time taken to complete closure in the operating room. 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.

Official Title
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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

Conditions
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Breast Hypertrophy, Abdominal Elastosis, Breast Reconstruction

Intervention / Treatment
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* Device: wound closure device (Steri-Strip™)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: wound closure device (Steri-Strip™)|wound closure with steri-strip S|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Postoperative Incisional Comfort | Using a comfort scale from 0-10 with 0 being very uncomfortable and 10 being very comfortable | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin closure devices, linear scars