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Trial Title:
Patient Satisfaction After Facial Reconstruction
NCT ID:
NCT02230462
Condition:
Skin Neoplasms
Conditions: Official terms:
Skin Neoplasms
Conditions: Keywords:
patient satisfaction
Mohs surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Viewing of cancer excision defect
Description:
Patients will be invited to view their cancer excision defect, with the aid of a mirror,
prior to its reconstruction.
Arm group label:
Viewing of cancer excision defect
Summary:
The purpose of this study is to assess the effects of visualization of skin cancer
resection defects on the face on the post-operative satisfaction of patients after their
reconstruction. To achieve this aim, patients invited to participate in this study will
be randomized to either seeing or not seeing their skin cancer excision defect prior to
reconstruction. After reconstruction, patient satisfaction will be assessed in both
groups to determine if visualization of the defect prior to reconstruction has any effect
on patient satisfaction and if any detected effect has durability over time.
Detailed description:
Purpose:
The purpose of this study is to assess patient satisfaction after reconstruction of Mohs
skin cancer resection defects in the face, with the resection defect either seen or
unseen by the patient. In this way, the investigators will determine the effects of
visualization of the pre-operative defects on patient satisfaction after facial
reconstruction. Any effects on patient satisfaction that are identified will then be
tracked over time.
Hypothesis:
The null hypothesis for this study is that patient satisfaction after reconstruction of
Mohs defects on the face is unaffected by the opportunity to visualize the defect prior
to reconstruction, and that this observation persists over time. Furthermore, patients
are able to recall the size of their cancer resection defect as accurately from a
detailed description as from seeing the defect in a mirror.
Justification:
This study will address whether visualization of a defect prior to its reconstruction
affects patient satisfaction. Visualization of a defect prior to reconstruction is not
standardized and is occasionally, but by no means necessarily, a portion of their consent
for the reconstruction procedure. For the excision and reconstruction procedure in this
study, all patients will be receiving the gold standard treatment for skin cancer. This
includes a Mohs excision of their cancer and subsequent reconstruction of the excision
defect using either primary closure or local flaps. Alternative treatments to this
approach include various forms of excision and reconstruction where cancer free margins
cannot be immediately determined.
Objectives:
The objectives of this study are to determine whether visualization of a cancer excision
defect on the face, prior to its reconstruction, improves post-reconstruction patient
satisfaction. The satisfaction measures sought will primarily be satisfaction with the
cosmetic result but will also include measures pertaining to symptomatic scarring, skin
related quality of life and ability to recall defect size will also be collected.
Research Method:
Patients meeting research criteria will be recruited to this study. These patients will
all undergo cancer excision and reconstruction of the skin cancer defect during the same
clinic visit. After their cancer excision is complete, they will be and randomized to
either viewing or not-viewing their skin cancer excision defect prior to its
reconstruction. After reconstruction they will be provided a series of surveys that
assess the research questions posed by this study. Surveys will be distributed in the
clinic on the day of surgery and at routine follow-up appointments at one week and two to
three months.
Statistical Analysis:
The planned sample size for this study is eighty patients randomized to two groups of
forty. Study end points will be sought from patient answers to three sets of surveys that
determine patient satisfaction with the cosmetic appearance of their reconstruction,
ranked on an ordinal scale, as a primary end-point. Secondary end points using ordinal
and binary measures will also be sought and include skin related quality of life (as
measured by the Skindex 16), scarring, and the ability to accurately recall the size of
the skin cancer excision defect. A chi-squared analysis of the data will be performed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients recruited for this study must undergo Mohs resection of skin cancer of the
face with negative margins at the completion of their cancer resection.
- Patients recruited for this study must have a post cancer resection defect on the
face at least 1.5 centimeters in size in the greatest dimension.
- Patients recruited for this study must undergo single stage repair of their post
cancer resection defect with primary closure or local flaps.
- Patients must be from the Greater Vancouver area.
Exclusion Criteria:
- Patients with insufficient visual acuity to be able to appreciate wound and scarring
changes to their face post-operatively will be excluded.
- Patients lacking the cognitive capacity to complete the data collection forms
utilized in this study will be excluded.
- Patients suffering from significant psychiatric conditions will be excluded.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dermatology & Skin Science (UBC), The Skin Care Centre
Address:
City:
Vancouver
Zip:
V5Z 4E8
Country:
Canada
Contact:
Last name:
Bryce J Cowan, MD, PhD
Phone:
604-875-4888
Email:
skinsurg@gmail.com
Contact backup:
Last name:
Jorga Zabojova, MD, PhD
Email:
jorga.zabojova@gmail.com
Investigator:
Last name:
Bryce J Cowan, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Jorga Zabojova, MD, PhD
Email:
Sub-Investigator
Start date:
October 2014
Completion date:
June 2015
Lead sponsor:
Agency:
University of British Columbia
Agency class:
Other
Source:
University of British Columbia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02230462