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

NCT05074212 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2025-06-03

No results posted yet for this study

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.

Conditions

  • Wound Heal
  • Wound of Skin

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).

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074212 on ClinicalTrials.gov