Secondary Intention Healing, Skin Cancer Healing, Skin Substitutes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALSkin Substitute
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.
BIOLOGICALSecondary Intention Healing
Standard secondary intention healing with daily wound care only.
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 and older undergoing Mohs micrographic surgery * Wounds deemed clinically appropriate for secondary intention healing * Ability to adhere to daily wound care and follow-up visits * Willingness to consent to standardized medical photography
Exclusion criteria
* Wounds requiring flap or graft reconstruction for structural/functional reasons * Active wound infection at time of reconstruction * Known allergy to any component of the skin substitute * Severe immunosuppression in which either approach may pose undue risk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Outcome Assessments | 12 weeks | 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". |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Healing | 12 weeks | 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. |
| Pain Scores | 12 weeks | 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. |
| Rate of Complications | 12 weeks | 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. |
| Scar Appearance | 12 weeks | 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". |
| Treatment-Related Resource Consumption | 12 weeks | To evaluate the resource utilization and cost of the number of clinic visits by reviewing the patients electronic health record |
| Patient Productivity Loss | 12 weeks | To assess the loss of productivity due to patient-reported time off work, if feasible. This will be done by patients verbal self-report. |
Countries
United States
Contacts
CONTACTUmer Nadir, MD
PRINCIPAL_INVESTIGATORStan Tolkachjov, MD
Baylor Scott and White Health
Outcome results
None listed