A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study
NCT ID: NCT04805905
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2021-04-30
2022-02-28
Brief Summary
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Detailed Description
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Upon completion of the feasibility study, a prospective pilot cohort study would be performed to measure outcomes using the FACE-Q Skin Cancer module for patients receiving skin grafting or local flaps after excision of facial skin cancers.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Skin graft
FACE-Q patient reported outcome
As both interventions of treatment are gold standards and clinical equipoise exists if one intervention is superior to the other, there is no true control group. However, for the purpose of the application, the local flap group will be chosen as the "control" group.
Skin graft (Experimental): Participants in the experimental group will receive a skin graft and receive the FACE-Q skin cancer questionnaire pre- and post-treatment. There will also be photos taken of the patient's face along with the distributed questionnaires.
Local flap (Control): Participants in the experimental group will receive a local flap and receive the FACE-Q questionnaire pre- and post-treatment.
Local flap
FACE-Q patient reported outcome
As both interventions of treatment are gold standards and clinical equipoise exists if one intervention is superior to the other, there is no true control group. However, for the purpose of the application, the local flap group will be chosen as the "control" group.
Skin graft (Experimental): Participants in the experimental group will receive a skin graft and receive the FACE-Q skin cancer questionnaire pre- and post-treatment. There will also be photos taken of the patient's face along with the distributed questionnaires.
Local flap (Control): Participants in the experimental group will receive a local flap and receive the FACE-Q questionnaire pre- and post-treatment.
Interventions
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FACE-Q patient reported outcome
As both interventions of treatment are gold standards and clinical equipoise exists if one intervention is superior to the other, there is no true control group. However, for the purpose of the application, the local flap group will be chosen as the "control" group.
Skin graft (Experimental): Participants in the experimental group will receive a skin graft and receive the FACE-Q skin cancer questionnaire pre- and post-treatment. There will also be photos taken of the patient's face along with the distributed questionnaires.
Local flap (Control): Participants in the experimental group will receive a local flap and receive the FACE-Q questionnaire pre- and post-treatment.
Eligibility Criteria
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Inclusion Criteria
* they are 18 years or older
* presenting for treatment of a suspected non-melanoma facial skin cancer, including pre-malignant cancers (i.e., actinic keratosis),
* and scheduled to undergo reconstruction with either a skin graft or local tissue flap.
Exclusion Criteria
* present with altered level of consciousness,
* cannot provide consent,
* have facial nerve injury/previous facial nerve injury, have Melanoma skin cancer or Merkel cell carcinoma based on pathology reports, have polytrauma/multiple injuries, are pregnant, are undergoing free flap reconstruction, have bone involvement, or if they are under the age of 18.
18 Years
ALL
Yes
Sponsors
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McMaster University
OTHER
Responsible Party
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Mark McRae
Principal Investigator
Central Contacts
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Other Identifiers
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8304
Identifier Type: -
Identifier Source: org_study_id
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