Clinical trial NCT05251064: Orthopaedic Surgical Wound Closure Comparison Study
Official title: Randomized Controlled Trial of Wound Closure Techniques in Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incision, Surgical
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stony Brook Scar Evaluation Scale
timeFrame: 2-Weeks post-operative
measure: Stony Brook Scar Evaluation Scale
timeFrame: 3-Months post operative
Secondary outcomes:
measure: Time to Close
timeFrame: During the procedure, from beginning of wound closure to the completion of wound closure
measure: Length of Incision
timeFrame: During the procedure, obtained after incision was closed.
measure: Patient Satisfaction
timeFrame: 2 weeks post operative
measure: Patient Satisfaction
timeFrame: 3 months post operative
measure: Surgeon Satisfaction
timeFrame: Once (at application)
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Mark Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burke JF, MacLean IS, Smith JM, Hart JM, Miller MD. A Prospective, Randomized, Controlled Comparison of Adhesive Wound Closure Devices in an Orthopaedic Patient. J Am Acad Orthop Surg Glob Res Rev. 2022 Sep 23;6(9):e22.00179. doi: 10.5435/JAAOSGlobal-D-22-00179. eCollection 2022 Sep 1.