NCT05251064

Orthopaedic Surgical Wound Closure Comparison Study

Completed NA Results posted Last updated 15 June 2025

What this trial tests

NA trial testing Suture in Incision, Surgical in 56 participants. Completed in 20 January 2022.

Timeline

23 April 2019

Primary endpoint
20 January 2022

20 January 2022

Quick facts

Lead sponsor	University of Virginia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	23 April 2019
Primary completion	20 January 2022
Estimated completion	20 January 2022
Sites	1 location across United States

Drugs / interventions tested

• Suture — full drug profile →
• Clozex
• Zipline

Conditions studied

• Incision, Surgical — all drugs for Incision, Surgical →

Sponsor

University of Virginia

Who can join

18 and older, any sex, with Incision, Surgical. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Stony Brook Scar Evaluation Scale Primary · 2-Weeks post-operative

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

Group	Value	95% CI
Suture	2.8	± 0.92
Adhesive Wound Closure Device	4.09	± 0.70
Adhesive Wound Closure Device With Zip Ties	3.45	± 1.21

Stony Brook Scar Evaluation Scale Primary · 3-Months post operative

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

Group	Value	95% CI
Suture	2.85	± 1.20
Adhesive Wound Closure Device	3.82	± 0.60
Adhesive Wound Closure Device With Zip Ties	3.0	± 0.89

Time to Close Secondary · During the procedure, from beginning of wound closure to the completion of wound closure

The amount of time in seconds that it took to perform closure of the incision.

Group	Value	95% CI
Suture	266.31	± 193.59
Adhesive Wound Closure Device	91.09	± 39.53
Adhesive Wound Closure Device With Zip Ties	123.27	± 124.23

Length of Incision Secondary · During the procedure, obtained after incision was closed.

This is the measure in centimeters of the incision.

Group	Value	95% CI
Suture	9.78	± 4.87
Adhesive Wound Closure Device	8.23	± 4.09
Adhesive Wound Closure Device With Zip Ties	8.1	± 2.78

Patient Satisfaction Secondary · 2 weeks post operative

Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction.

Group	Value	95% CI
Suture	8.33	± 1.66
Adhesive Wound Closure Device	8.82	± 1.33
Adhesive Wound Closure Device With Zip Ties	8.64	± 1.8

Patient Satisfaction Secondary · 3 months post operative

Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower patient satisfaction.

Group	Value	95% CI
Suture	8.11	± 1.95
Adhesive Wound Closure Device	8.727	± 1.73
Adhesive Wound Closure Device With Zip Ties	8.82	± 1.47

Surgeon Satisfaction Secondary · Once (at application)

Scores range from 0-10. Higher scores indicate better satisfaction. Lower scores indicate lower satisfaction.

Group	Value	95% CI
Suture	7.11	± 3.62
Adhesive Wound Closure Device	8.18	± 2.09
Adhesive Wound Closure Device With Zip Ties	8.0	± 1.55

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Suture

Serious: 0/19 (0%)

Deaths: 0/19

Adhesive Wound Closure Device

Serious: 0/19 (0%)

Deaths: 0/19

Adhesive Wound Closure Device With Zip Ties

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (2 terms — click to expand)

Reaction	System	Suture	Adhesive Wound Closure Dev…	Adhesive Wound Closure Dev…
blisters	Skin and subcutaneous tissue disorders	—	—	—
cellulitis	Skin and subcutaneous tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT05251064 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Prospective, Randomized, Controlled Comparison of Adhesive Wound Closure Devices in an Orthopaedic Patient.
   Burke JF, MacLean IS, Smith JM, Hart JM, et al · · 2022 · cited 1× · PMID 36155955 · DOI 10.5435/jaaosglobal-d-22-00179