Skin CancerNCT05643755
Preoperative Image-based Education Effect on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery
A study testing Preoperative image-based education in people with Skin Cancer and Skin Wound, run by Johns Hopkins University.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer, Skin Wound
- What is being tested?
- Preoperative image-based education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2025
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who have already undergone dermatology surgery.
- Patients whose incisions are not closed with primary closure
About this study
Official title: 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.
Read the 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.
- Conditions
- Skin Cancer, Skin Wound
- Being tested
- Preoperative image-based education
- Keywords
- Mohs Surgery, Wide Local Excision
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative image-based educationOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Preoperative image-based education |
| Control | No intervention | Control group: standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of surgery
Secondary outcomes (1)
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
Measured: Up to 4 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study startDec 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Lack of personnel to complete study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Skin CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise Ng, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643755
- Sponsor's protocol ID
- IRB00357538
- Status last verified
- Apr 2024
- First submitted
- 30 Nov 2022
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25654193Dixon 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.
PubMed 17707149Cassileth 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.
PubMed 6849025Long 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.
PubMed 35438652Pereira 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.
PubMed 26654958Sobanko 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.
PubMed 27923500Arzeno 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.
PubMed 34387069Patel 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.
PubMed 32785836
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Preoperative Image-based Education on Postoperative Satisfaction of Patients Undergoing First-time Dermatologic Surgery
- ClinicalTrials.gov ID
- NCT05643755
- Acronym / sponsor ID
- IRB00357538
- Conditions
- Skin Cancer, Skin Wound
- Keywords
- Mohs Surgery, Wide Local Excision
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of personnel to complete study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Dec 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Preoperative image-based educationIntervention 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 | No intervention | –Control group: standard clinical care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who have already undergone dermatology surgery.
- Patients whose incisions are not closed with primary closure
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 |
|---|---|---|
| Preoperative image-based educationIntervention 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) | Other | Intervention |
Primary outcome
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.
1 secondary outcome
Patient factors associated with satisfaction with wound appearance as assessed by Modified Skin Cancer Index questionnaire
Time frame: Up to 4 weeks after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Background: PubMed 25654193Sobanko 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.
- Background: PubMed 17707149Dixon 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.
- Background: PubMed 6849025Cassileth 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.
- Background: PubMed 35438652Long 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.
- Background: PubMed 26654958Pereira 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.
- Background: PubMed 27923500Sobanko 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.
- Background: PubMed 34387069Arzeno 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.
- Background: PubMed 32785836Patel 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.
- Individual participant dataSharing planned: No
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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.
Elise Ng, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative image-based education in people with Skin Cancer and Skin Wound, run by Johns Hopkins University.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643755, which also lists 8 linked publications.
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 8 Apr 2024.