search
Back to results

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

Primary Purpose

Skin Cancer, Skin Wound

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Preoperative image-based education
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Skin Cancer focused on measuring Mohs Surgery, Wide Local Excision

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    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)

    Control group: standard clinical care

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 30, 2022
    Last Updated
    October 10, 2023
    Sponsor
    Johns Hopkins University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05643755
    Brief Title
    Preoperative Image-based Education Effect on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery
    Official Title
    Investigating the Effect of Preoperative Image-based Education on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    August 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Cancer, Skin Wound
    Keywords
    Mohs Surgery, Wide Local Excision

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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)
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Control group: standard clinical care
    Intervention Type
    Other
    Intervention Name(s)
    Preoperative image-based education
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Patient satisfaction with wound appearance immediately after surgery in control vs. intervention groups as assessed by the Modified Skin Cancer Index questionnaire
    Description
    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.
    Time Frame
    At time of surgery
    Secondary Outcome Measure Information:
    Title
    Patient factors associated with satisfaction with wound appearance as assessed by Modified Skin Cancer Index questionnaire
    Description
    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
    Time Frame
    Up to 4 weeks after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elise Ng, MD
    Phone
    410-955-5933
    Email
    eng9@jhmi.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emanuelle Rizk
    Email
    erizk2@jhmi.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elise Ng, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25654193
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17707149
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    6849025
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    35438652
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26654958
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27923500
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34387069
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32785836
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs