Clinical trial NCT05074212: Aesthetic Outcome of Complex Linear Closure vs Second Intention Healing: Below the Knee
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Wound Heal
Wound of Skin
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: POSAS
timeFrame: 3-12 months
measure: Mean Scar Width
timeFrame: 3-12 months
Secondary outcomes:
measure: Occurrence of Complications
timeFrame: 3-12 months
measure: Quality of Life Measures (DLQI)
timeFrame: 3-12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis, Department of Dermatology
state: California
Study officials:
References: