Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

The purpose of this study is to determine whether electrodesiccation and curettage (ED&C) versus excision with complex linear closure affects esthetic outcomes (primary outcome). As secondary outcome, we plan 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 ED&C and the other half will receive excision with repair by complex linear closure. 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 Electrodesiccation and Curettage vs Excision With Complex Linear Closure for Low Risk Lesions on the Trunk and Extremities: a Randomized, Blind Control Trial

Details

Low risk lesions on the trunk and extremities can be treated via various modalities including topical therapies, ED&C, and excision. The purpose of this study is to compare ED&C versus excision with repair by complex linear closure. The wound following ED&C will heal by second intention, meaning that there will not be any sutures placed. Complex linear closures following an excision will require two layers of sutures: a deep (subcutaneous) layer and a top (cutaneous) layer.

This study aims to investigate whether ED&C versus excision with repair by complex linear closure for low risk lesions on trunk and extremities affects cosmesis. In other words, the research team would like to determine which of the following yields a more cosmetically appealing scar: ED&C or excision with linear closure. As secondary outcomes, the research team plans to look at quality of life measures via a validated survey and complications.

There has been a prospective cohort study measuring quality of life following ED&C vs excision vs Mohs surgery1 and another prospective cohort study measuring patient reported outcomes following ED&C2. However, randomized control trials comparing the cosmesis and quality of life of these two methods appear to be lacking in current literature. The research team hopes that this study will provide new insight in cutaneous surgery.

Keywords

Cutaneous Surgery, Electrodesiccation and Curettage vs Excision, Excision

Eligibility

You can join if…

Open to people ages 18 years and up

You CAN'T join if...

  • Incarceration
  • Under 18 years of age
  • Pregnant Women
  • Lesion size equal to or greater than 2 cm.
  • Aggressive tumor subtypes(invasive squamous cell carcinoma (any subtype), infiltrative(sclerosing) basal cell carcinoma, micronodular basal cell carcinoma.
  • Recurrent tumors

Location

  • University of California, Davis
    Sacramento California 95816 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT05074225
Study Type
Interventional
Participants
Expecting 172 study participants
Last Updated