The purpose of this study is to compare two ways of caring for wounds after Mohs micrographic surgery (MMS) for skin cancer using skin substitutes and secondary intention healing, to determine which option leads to better healing after Mohs surgery.
This is a randomized-controlled trial comparing two ways of caring for wounds after Mohs micrographic surgery for skin cancer: skin substitutes, which are special wound-healing materials that may help wounds heal, and secondary intention healing, a common method in which wounds are allowed to heal on their own. This research is being done because we do not yet know which option leads to better healing after Mohs surgery. Patients will be randomized into one of two groups and receive either the skin substitute or undergo secondary intention healing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Application of a commercially available skin substitute (e.g., acellular dermal matrix or fish-skin xenograft) to the wound base followed by routine daily wound care.
Standard secondary intention healing with daily wound care only.
Baylor University Medical Center
Dallas, Texas, United States
Cosmetic Outcome Assessments
Compare cosmetic outcomes at 12 weeks between wounds treated with (1) a skin substitute and (2) secondary intention healing alone. This will be done by a group of blinded independent reviewers using standardized photographs and the Patient and Observer Scar Assessment Scale (POSAS), which evaluates scar quality using a scale of 1-10, where 1 is "like normal skin" and 10 is the "worst imaginable".
Time frame: 12 weeks
Complete Wound Healing
Assess the amount of time to took for the wound to heal completely, also defined as full epithelialization. This will be compared using a t-test model or the Mann-Whitney U tests. A t-test model uses an standard statistic test that is used to determine if there is significant differences between two groups. The Mann-Whitney U tests is a rank-sum test that is used to determine if there is a difference between two different groups.
Time frame: 12 weeks
Pain Scores
Evaluate the patient-reported pain during the first 2 weeks of healing and weekly, at follow-up visits, until wound closure. Patients will verbally rating their pain on a scale of 1-10 where 1 is no pain and 10 is severe pain. Patient will keep a record of their daily pain levels and share the scores at their weekly follow-up visits.
Time frame: 12 weeks
Rate of Complications
To determine the rate of complication and assess for infection, bleeding, hypergranulation, and unplanned interventions. During the follow-up visits the physician will conduct a visual assessment for these items and will use a chi-square or Fisher's exact tests. A Chi-Square test is a statistical tool that is used to determine if there is a different between expected and observed frequences in one or more category. Fisher's exact test is a tool used to determine if there are non-random associations between two categorical variables.
Time frame: 12 weeks
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Scar Appearance
To evaluate the patient-reported scar satisfaction by patients the Patient and Observer Scar Assessment Scale (POSAS), which evaluates scar quality using a scale of 1-10, where 1 is "like normal skin" and 10 is the "worst imaginable".
Time frame: 12 weeks
Treatment-Related Resource Consumption
To evaluate the resource utilization and cost of the number of clinic visits by reviewing the patients electronic health record
Time frame: 12 weeks
Treatment-Related Resource Consumption
To evaluate the resource utilization and cost of dressing supplies by reviewing the patients electronic health record.
Time frame: 12 weeks
Patient Productivity Loss
To assess the loss of productivity due to patient-reported time off work, if feasible. This will be done by patients verbal self-report.
Time frame: 12 weeks