Skin Subs vs Secondary Intention
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaylor Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Skin Substitute
Biological/VaccineApplication 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.
Secondary Intention Healing
Biological/VaccineStandard secondary intention healing with daily wound care only.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupActive comparator 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: