Preoperative Image-based Education Effect on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery

April 4, 2024 updated by: Johns Hopkins University

Investigating the Effect of Preoperative Image-based Education on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Undergoing surgery is a stressful process for many patients. By its nature, dermatologic surgery carries additional stressors given that it is performed on the skin, a very cosmetically sensitive area. In our dermatologic surgery practice, we have found that patients are often surprised by the length of their surgical wound immediately post-surgery; many have expressed confusion about the length of the wound relative to the much smaller targeted lesion.

Our research study will utilize image-based education prior to patients' first dermatologic surgery to determine whether this intervention helps patients feel more satisfied with their wound appearance immediately post-surgery. Our primary hypothesis is that patients who are undergoing dermatologic surgery for the first time will benefit from image-based education about the surgical wound closure process. We hypothesize that a greater proportion of such patients would feel more satisfied and less distressed with the cosmetic outcomes immediately after their surgery relative to patients who did not receive image-based education.

If this hypothesis is found to be true, we will conclude that there is a need for better patient education prior to their dermatologic surgery procedure. We hope that this study will create a framework for sharing educational resources with patients so that they may set expectations as to surgical outcomes. These findings may also be relevant to other surgical procedures where patient satisfaction would be improved by the implementation of pre-operative education.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Inclusion criteria: Adult patients (ages 18-100) who will be undergoing dermatology surgery at Johns Hopkins. We will include only patients who are undergoing their first dermatology surgery. Only patients whose incisions are closed with primary closure will be eligible.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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)
No Intervention: Control
Control group: standard clinical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with wound appearance immediately after surgery in control vs. intervention groups as assessed by the Modified Skin Cancer Index questionnaire
Time Frame: At time of surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient factors associated with satisfaction with wound appearance as assessed by Modified Skin Cancer Index questionnaire
Time Frame: Up to 4 weeks after surgery
We will collect information from the patient chart (including demographic factors, medical comorbidities, wound characteristics) to correlate these factors with patient satisfaction with their wound appearance
Up to 4 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Elise Ng, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00357538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Cancer

Clinical Trials on Preoperative image-based education

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe