Orthopaedic Surgical Wound Closure Comparison Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Controlled Trial of Wound Closure Techniques in Orthopaedic Surgery

Conditions
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Incision, Surgical

Intervention / Treatment
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* Device: Suture
* Device: Clozex
* Device: Zipline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18+ Patient scheduled to undergo elective orthopaedic surgical procedure with a minimum anticipated incision length of 3 cm. Willingness and ability to comply with scheduled visits and study procedures. Exclusion Criteria: Revision Surgery Compromised wound healing (autoimmune disorder, chronic steroids, connective tissue disorder) Pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, educational or economically disadvantage, non-English speaking subjects.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture<br>Standard suture wound closure | Device: Suture<br>* Standard suture wound closure device.<br>|
| Active Comparator: Adhesive wound closure device<br>Clozex wound closure device | Device: Clozex<br>* Interlaced adhesive wound closure device.<br>|
| Active Comparator: Adhesive wound closure device with zip ties<br>Zipline wound closure device | Device: Zipline<br>* Adhesive wound closure device using zip-tie like strips.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stony Brook Scar Evaluation Scale | Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing | 2 weeks post-operative |