Orthopaedic Surgical Wound Closure Comparison Study

NCT05251064 | Completed Results FDA Device

• 1 other identifier: 21411
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Incision, Surgical

Outcome Measures

Primary Outcomes (2)

• 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

• Stony Brook Scar Evaluation Scale

  Scores range from 0-5. Higher scores indicate better scar healing. Lower scores indicate worse scar healing

  3-Months post operative

Secondary Outcomes (5)

• Time to Close

  During the procedure, from beginning of wound closure to the completion of wound closure

• Length of Incision

  During the procedure, obtained after incision was closed.

• Patient Satisfaction

  2 weeks post operative

• Patient Satisfaction

  3 months post operative

• Surgeon Satisfaction

  Once (at application)

Study Arms (3)

Suture

ACTIVE COMPARATOR

Standard suture wound closure

Device: Suture

Adhesive wound closure device

ACTIVE COMPARATOR

Clozex wound closure device

Device: Clozex

Adhesive wound closure device with zip ties

ACTIVE COMPARATOR

Zipline wound closure device

Device: Zipline

Interventions

Suture DEVICE

Standard suture wound closure device.

Suture

Clozex DEVICE

Interlaced adhesive wound closure device.

Adhesive wound closure device

Zipline DEVICE

Adhesive wound closure device using zip-tie like strips.

Adhesive wound closure device with zip ties

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 36155955 DERIVED

MeSH Terms

Conditions

Surgical Wound

Interventions

Sutures

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Dr. Mark Miller
• Organization: University of Virginia

mdm3p@uvahealth.org

(434) 243-7778

Study Officials

• Mark Miller, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 22, 2022
• Study Start: April 23, 2019
• Primary Completion: January 20, 2022
• Study Completion: January 20, 2022
• Last Updated: June 15, 2025
• Results First Posted: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)