NCT05643755

Brief Summary

This research study aims to understand whether visual and written education on wound appearance can improve patients' experience and understanding of what their wound will look like following dermatologic surgery.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2025

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
3 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

November 30, 2022

Last Update Submit

April 4, 2024

Conditions

Keywords

Mohs SurgeryWide Local Excision

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction with wound appearance immediately after surgery in control vs. intervention groups as assessed by the Modified Skin Cancer Index questionnaire

    Whether the wound appearance is as expected, worse than expected, or better than expected immediately after surgery in control vs. intervention groups. We will administer the Modified Skin Cancer Index questionnaire to determine patient satisfaction with their wound appearance and compare satisfaction between control and intervention groups.

    At time of surgery

Secondary Outcomes (1)

  • Patient factors associated with satisfaction with wound appearance as assessed by Modified Skin Cancer Index questionnaire

    Up to 4 weeks after surgery

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group: educational material provided on the day of surgery containing pictographic and written education material on wound appearance following primary closure after Mohs Micrographic Surgery (MMS) or Wide Local Excision (WLE)

Other: Preoperative image-based education

Control

NO INTERVENTION

Control group: standard clinical care

Interventions

Intervention group: education handout containing pictographic and written education material on wound appearance following primary closure after Mohs Micrographic Surgery (MMS) or Wide Local Excision (WLE)

Intervention

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients who have already undergone dermatology surgery.
  • Patients whose incisions are not closed with primary closure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Sobanko JF, Sarwer DB, Zvargulis Z, Miller CJ. Importance of physical appearance in patients with skin cancer. Dermatol Surg. 2015 Feb;41(2):183-8. doi: 10.1097/DSS.0000000000000253.

    PMID: 25654193BACKGROUND
  • Dixon AJ, Dixon MP, Dixon JB. Prospective study of long-term patient perceptions of their skin cancer surgery. J Am Acad Dermatol. 2007 Sep;57(3):445-53. doi: 10.1016/j.jaad.2007.02.006.

    PMID: 17707149BACKGROUND
  • Cassileth BR, Lusk EJ, Tenaglia AN. Patients' perceptions of the cosmetic impact of melanoma resection. Plast Reconstr Surg. 1983 Jan;71(1):73-5. doi: 10.1097/00006534-198301000-00016.

    PMID: 6849025BACKGROUND
  • Long J, Rajabi-Estarabadi A, Levin A, Nami N, Nouri K. Perioperative Anxiety Associated With Mohs Micrographic Surgery: A Survey-Based Study. Dermatol Surg. 2022 Jul 1;48(7):711-715. doi: 10.1097/DSS.0000000000003455. Epub 2022 Apr 18.

    PMID: 35438652BACKGROUND
  • Pereira L, Figueiredo-Braga M, Carvalho IP. Preoperative anxiety in ambulatory surgery: The impact of an empathic patient-centered approach on psychological and clinical outcomes. Patient Educ Couns. 2016 May;99(5):733-8. doi: 10.1016/j.pec.2015.11.016. Epub 2015 Nov 26.

    PMID: 26654958BACKGROUND
  • Sobanko JF, Da Silva D, Chiesa Fuxench ZC, Modi B, Shin TM, Etzkorn JR, Samimi SS, Wanat KA, Miller CJ. Preoperative telephone consultation does not decrease patient anxiety before Mohs micrographic surgery. J Am Acad Dermatol. 2017 Mar;76(3):519-526. doi: 10.1016/j.jaad.2016.09.027. Epub 2016 Dec 4.

    PMID: 27923500BACKGROUND
  • Arzeno J, Liu R, Goldbach H, Moon D, Soriano T, Beynet D, Greco J, Ms MS, Kim J. Effect of pre-operative informational video on Mohs surgery patient experience. Dermatol Online J. 2021 Jun 15;27(6). doi: 10.5070/D327654069. No abstract available.

    PMID: 34387069BACKGROUND
  • Patel P, Malik K, Khachemoune A. Patient education in Mohs surgery: a review and critical evaluation of techniques. Arch Dermatol Res. 2021 May;313(4):217-224. doi: 10.1007/s00403-020-02119-5. Epub 2020 Aug 12.

    PMID: 32785836BACKGROUND

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Elise Ng, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 9, 2022

Study Start

December 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share