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ENROLLING BY INVITATION
NCT05074212
NA

Aesthetic Outcome of Complex Linear Closure vs Second Intention Healing: Below the Knee

Sponsor: University of California, Davis

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether complex linear closure vs second intention healing for cutaneous wounds below the knee affects esthetic outcomes (primary outcome). As secondary outcome, the study team plans to look at patient quality of life measures and complications. This will be a prospective, 2-arm, randomized, evaluator-blinded clinical trial. One half of the patients will receive repair by complex linear closure and the other half of the patients will undergo second intention healing. Three-months post-surgery, the scar will be evaluated via the patient observer scar assessment scale (POSAS), a validated scar instrument, as well as the trace-to-tape method, an objective outcome measure for linear postoperative scars. In addition, patients will be provided a validated quality of life survey to complete. Any adverse events will also be recorded.

Official title: Aesthetic Outcome of Complex Linear Closure vs Second Intention Healing for Cutaneous Surgical Procedures Performed Below the Knee: a Randomized, Blind Control Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

172

Start Date

2022-01-10

Completion Date

2030-12

Last Updated

2025-06-03

Healthy Volunteers

No

Interventions

OTHER

Factorial Assignment

At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).

Locations (1)

University of California, Davis, Department of Dermatology

Sacramento, California, United States