N/A
N=56
Orthopaedic Surgical Wound Closure Comparison Study
Incision, Surgical
Bottom Line
View on ClinicalTrials.gov: NCT05251064 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Stony Brook Scar Evaluation Scale — 2.8; 4.09; 3.45 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Suture (Device); Clozex (Device); Zipline (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Virginia
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stony Brook Scar Evaluation Scale |
2.85; 3.82; 3.0 | — |
| PRIMARY Stony Brook Scar Evaluation Scale |
2.85; 3.82; 3.0 | — |
| SECONDARY Time to Close |
266.31; 91.09; 123.27 | — |
| SECONDARY Length of Incision |
9.78; 8.23; 8.1 | — |
| SECONDARY Patient Satisfaction |
8.11; 8.727; 8.82 | — |
| SECONDARY Patient Satisfaction |
8.11; 8.727; 8.82 | — |
| SECONDARY Surgeon Satisfaction |
7.11; 8.18; 8.0 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05251064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.