This study is trying to find out if there is one method of surgical incision closure is better than another. The three different wound closure methods in this study are currently used in standard of care. The three methods being compared are standard stitches and the wound closure devices, Clozex, and Zipline. All of these methods are approved by the FDA.
There are many surgical wound closure methods commonly used in practice today. These usually involve a combination of braided and monofilament sutures in the subcutaneous fascia and fat as well as the subcuticular layers of the skin. The methods chosen by surgeons vary widely even amongst partners at the same institution for many reasons, including training background and conflicting reports in the literature. In some cases, these closure techniques can be time consuming and associated with increased rates of poor cosmetic outcomes or complications. There have been new wound closure products to reach the market that have been designed (Zipline - Campbell, CA and Clozex - Wellesley, MA), claiming to increase the speed of closure and decrease the rate of complications. These products both utilize an adhesive backed film to adhere to the skin along with a proprietary method to enhance skin apposition to reduce tension during the healing process. There has been no randomized controlled trial to determine superiority of the above listed surgical closure methods compared to traditional methods. Our study aims to compare a "traditional" wound closure using both braided and monofilament sutures to the newer wound closure systems. By determining which method provides superior results, we will improve patient outcomes and satisfaction. The study also aims to assess health care value by exploring the costs associated with each closure technique. In addition to material expenses associated with the traditional sutures, we seek to explore if there is a significant difference in the time required to perform each wound closure method. Every minute of anesthesia and operating room utilization is associated with costs borne by the patient and the health care system. By finding which closure method is the fastest and associated with the best outcome we can improve healthcare value. These methods will be tested in a randomized controlled trial and will be analyzed with multivariate statistical analysis to examine statistical significance. Subjects will be randomized in a 1:1:1 fashion to sutures, Closex, or Zipline. Surgeons will complete a satisfaction questionnaire about the randomized method used for closure. Surgical subjects will complete a satisfaction questionnaire at two follow up visits that align with standard of care visits and will have the incision measured and examined. Our primary objective outcome measure will be an assessment of surgical scar dimensions. Our hypothesis is that the 3 study groups will have similar objective scar measurements but that the savings in time associated with the new wound closure methods will be significant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
56
University of Virginia
Charlottesville, Virginia, United States
Stony Brook Scar Evaluation Scale
Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing
Time frame: 2-Weeks post-operative
Stony Brook Scar Evaluation Scale
Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing
Time frame: 3-Months post operative
Time to Close
The amount of time in seconds that it took to perform closure of the incision.
Time frame: During the procedure, from beginning of wound closure to the completion of wound closure
Length of Incision
This is the measure in centimeters of the incision.
Time frame: During the procedure, obtained after incision was closed.
Patient Satisfaction
Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction.
Time frame: 2 weeks post operative
Patient Satisfaction
Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction.
Time frame: 3 months post operative
Surgeon Satisfaction
Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower satisfaction.
Time frame: Once (at application)
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