Cutaneous SurgeryNCT05074225
Aesthetic Outcome of Electrodesiccation and Curettage vs Excision With Complex Linear Closure
A study testing Electrodesiccation and Curettage vs Excision in people with Cutaneous Surgery, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Surgery
- What is being tested?
- Electrodesiccation and Curettage vs Excision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 8 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Sacramento, California, 95816
About this study
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
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.
Read the 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
- Being tested
- Electrodesiccation and Curettage vs Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrodesiccation and Curettage vs ExcisionOther
Factorial Assignment.
At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).
| Study group | Role | What they receive |
|---|---|---|
| ED&C | Experimental | The ED\&C arm will receive the standard ED\&C care. Receives: Other: Electrodesiccation and Curettage vs Excision |
| Excision | Experimental | The excision arm will undergo standard excision with repair by complex linear closure. Receives: Other: Electrodesiccation and Curettage vs Excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-12 months
Secondary outcomes (2)
Complications
The following complications from the treatment will be evaluated: spitting sutures, dehiscence, infection, necrosis, bleeding, and hematoma.
Measured: 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.
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start3 Feb 2020
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074225
- Sponsor's protocol ID
- 1515118
- Status last verified
- May 2024
- First submitted
- 29 Sep 2021
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05074225
- Acronym / sponsor ID
- 1515118
- Conditions
- Cutaneous Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED&C | Experimental | Other: Electrodesiccation and Curettage vs ExcisionThe ED\&C arm will receive the standard ED\&C care. |
| Excision | Experimental | Other: Electrodesiccation and Curettage vs ExcisionThe excision arm will undergo standard excision with repair by complex linear closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrodesiccation and Curettage vs ExcisionFactorial Assignment. At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS). | Other | ED&C, Excision |
Primary outcome
Scar Assessment
Time frame: 3-12 months
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.
2 secondary outcomes
Complications
Time frame: 3-12 months
Quality of Life Measures (DLQI)
Time frame: 3-12 months
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrodesiccation and Curettage vs Excision in people with Cutaneous Surgery, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Assessment (time frame: 3-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.