Orthopaedic Surgical Wound Closure Comparison Study

Randomized Controlled Trial of Wound Closure Techniques in Orthopaedic Surgery

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.

Study Overview

• Status: Completed
• Conditions: Incision, Surgical
• Intervention / Treatment: Device: Suture; Device: Clozex; Device: Zipline

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Suture; Standard suture wound closure	Device: Suture; Standard suture wound closure device.
ACTIVE_COMPARATOR: Adhesive wound closure device; Clozex wound closure device	Device: Clozex; Interlaced adhesive wound closure device.
ACTIVE_COMPARATOR: Adhesive wound closure device with zip ties; Zipline wound closure device	Device: Zipline; Adhesive wound closure device using zip-tie like strips.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Mark Miller, MD, University of Virginia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 23, 2019
• Primary Completion (ACTUAL): January 20, 2022
• Study Completion (ACTUAL): January 20, 2022

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (ACTUAL): February 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 21411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will not be share. Group means will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes