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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cutaneous Surgery
• Intervention / Treatment: Other: Electrodesiccation and Curettage vs Excision

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ED&C; The ED&C arm will receive the standard ED&C care.	Other: 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).
Experimental: Excision; The excision arm will undergo standard excision with repair by complex linear closure.	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Assessment	The primary endpoints will be (1) the score of two blinded reviewers using the patient observer scar assessment score and (2) the mean scar area to preoperative cancer area ratio using the trace-to-tape method at a three-month assessment visit.	3-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	The following complications from the treatment will be evaluated: spitting sutures, dehiscence, infection, necrosis, bleeding, and hematoma.	3-12 months
Quality of Life Measures (DLQI)	The aim of this questionnaire is to measure how much study participant skin problem has affected their life. The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week.	3-12 months

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): June 8, 2022
• Study Completion (Actual): June 8, 2022

Study Registration Dates

• First Submitted: September 29, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1515118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No