Aesthetic Outcome of Electrodesiccation and Curettage vs Excision With Complex Linear Closure

NCT ID: NCT05074225

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2022-06-08

Brief 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.

Detailed Description

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.

Conditions

Cutaneous Surgery

Study Design

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

Study Groups

ED&C

The ED\&C arm will receive the standard ED\&C care.

Group Type: EXPERIMENTAL

Electrodesiccation and Curettage vs Excision

Intervention Type: 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).

Excision

The excision arm will undergo standard excision with repair by complex linear closure.

Group Type: EXPERIMENTAL

Electrodesiccation and Curettage vs Excision

Intervention Type: 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).

Interventions

Electrodesiccation and Curettage vs Excision

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 treatment of low risk cutaneous neoplasms on the trunk or extremities (superficial or nodular basal cell carcinoma and squamous cell carcinoma in-situ).
• Willing to return for follow up visit

Exclusion Criteria

• 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

• 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

Sacramento, California, United States

Countries

United States

Other Identifiers

1515118

Identifier Type: -

Identifier Source: org_study_id