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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05643755
Other study ID # IRB00357538
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 2025
Est. completion date December 2025

Study information

Verified date April 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Up to 4 weeks after surgery
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