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

NCT05074212 | Enrolling By Invitation

• 1 other identifier: 1515109
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• POSAS

  The primary outcome is the sum of the average components of the Observer portion of the Patient and Observer Scar Assessment Scale (POSAS). The observer scale of the POSAS consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area). All items are scored on a scale ranging from 1 ('like normal skin') to 10 ('worst scar imaginable'). The sum of the six items results in a total score of the POSAS observer scale. Categories boxes are added for each item. Furthermore, an overall opinion is scored on a scale ranging from 1 to 10.

  3-12 months

• Mean Scar Width

  Mean scar width will be measured using the trace-to-tape method.

  3-12 months

Secondary Outcomes (2)

• Occurrence of Complications

  3-12 months

• Quality of Life Measures (DLQI)

  3-12 months

Study Arms (2)

Complex Linear Closure

EXPERIMENTAL

The study participant will receive two layers of sutures to close the wound.

Other: Factorial Assignment

Second Intention Healing

EXPERIMENTAL

The study participant will not have any sutures placed.

Other: Factorial Assignment

Interventions

Factorial Assignment OTHER

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

Complex Linear Closure; Second Intention Healing

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Able to give informed consent themselves
• Patient scheduled for cutaneous surgical procedure below the knee with a lesion excision diameter of at least 1 cm.
• Willing to return for follow up visit

You may not qualify if:

• Incarceration
• Under 18 years of age
• Pregnant Women

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: January 10, 2022
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)