Clinical trial NCT04805905: A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study
Official title: A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Cancer, Basal Cell
Skin Cancer
Skin Cancer, Non-Melanoma
Skin Cancers - Squamous Cell Carcinoma
Patient Satisfaction
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be included in the study if 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. Patients will be excluded in the study if they: 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.

Brief summary: A prospective single-centered feasibility study will be conducted. The purpose of the feasibility study is to define the variables to be included in a subsequent pilot study, assess the feasibility of conducting a prospective cohort study, and the logistics for the study (i.e., training, patient recruitment, data collection, statistical analysis, etc.).

Detailed description: A prospective single-centered feasibility study will be conducted. The purpose of the feasibility study is to define the variables to be included in a subsequent pilot study, assess the feasibility of conducting a prospective cohort study, and the logistics for the study (i.e., training, patient recruitment, data collection, statistical analysis, etc.).

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.

Eligibility criteria: Inclusion Criteria:

Patients will be included in the study if:

* 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:

Patients will be excluded in the study if they:

* 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: 12 months
measure: Retention rate
timeFrame: 3 months from surgery
measure: Compliance rate
timeFrame: 12 months
measure: Eligible patients
timeFrame: 12 months
Secondary outcomes:
measure: FACE-Q score
timeFrame: 12 months
measure: Facial photos
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: