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

NCT ID: NCT05074212

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2030-12-31

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.

Detailed Description

When a cutaneous wound is created following Mohs micrographic surgery and standard excisions, a decision is made to either allow the wound to heal by second intention ("leave open") or repair the wound ("close"). The decision may depend on patient characteristics, wound location, wound size or wound characteristics.

When the decision is made to repair the wound, the majority of wounds are reconstructed using two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer.

This study aims to investigate whether complex linear closure versus second intention healing for cutaneous surgical procedures performed below the knee affects wound cosmesis. In other words, the study team would like to determine which of the following yields a more cosmetically appealing scar: below the knee wound that is closed in a linear fashion or below the knee wound that is left open to heal on its own. The study team also plans to look at quality of life measures via validated surveys and complications.

Randomized control trials comparing these two methods appear to be lacking. A randomized trial looked at second intention healing vs primary simple closure following 4mm or 8mm punch biopsies on the arm, back or thigh1. Besides this study, no other information could be found in the literature on randomized trials comparing linear closure vs second intent for cutaneous wounds below the knee. The study team hopes that this study will provide new insight in cutaneous surgery.

Conditions

Wound Heal; Wound of Skin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Complex Linear Closure

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

Group Type: EXPERIMENTAL

Factorial Assignment

Intervention Type: OTHER

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

Second Intention Healing

The study participant will not have any sutures placed.

Group Type: EXPERIMENTAL

Factorial Assignment

Intervention Type: OTHER

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

Interventions

Factorial Assignment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 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

Exclusion Criteria

• Incarceration
• Under 18 years of age
• Pregnant Women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California, Davis, Department of Dermatology

Sacramento, California, United States

Countries

United States

Other Identifiers

1515109

Identifier Type: -

Identifier Source: org_study_id