Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery

Study Overview
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Brief Summary
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The primary objects of this study is to explore the potential effect of the autologous patch to optimize wound healing after skin cancer surgery with Mohs micrographic surgery (MMS) in the face in a randomized controlled trial comparing autologous patch healing versus secondary intention healing.

Official Title
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Autologous Patch Healing vs. Secondary Intention Healing After Mohs Micrographic Surgery - A Randomized Controlled Trial

Conditions
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Skin Cancer, Basal Cell Carcinoma

Intervention / Treatment
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* Procedure: MMS + Autologous patch
* Procedure: MMS and secondary intention healing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects undergoing MMS for biopsy verified primary nodular basal cell carcinoma in the face, head and neck area on a location suitable for secondary intention healing and thus may also be suitable for autologous patch healing Presenting relevant medical record report at study initiation Written informed consent obtained from subject Understanding of investigation procedures and willingness to abide to all procedures during the course of the investigation. Exclusion Criteria: A subjects with major systemic disease not yet stabilized Significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study. Pregnant or breast feeding Unable to follow the outlined study protocol Participation in other studies at the same time that may affect the wound healing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMS + Autologous patch<br>Mohs micrographic surgery + Autologus patch formed from 18 ml venous blood sample collected from the patient + polymycin-terramycin B ointment and a Jelonet applied on top of the patch. | Procedure: MMS + Autologous patch<br>* A patch of consisting of platelets, leucocytes and fibrin, formed by the patients own blood sample.<br>|
| Active Comparator: MMS + Secondary intention healing<br>Mohs micropgraphic surgery + Polymycin-terramycin B ointment + dry wound dressing | Procedure: MMS and secondary intention healing<br>* Mohs micrographic surgery (standard of care) (wounds will heal by secondary intention healing)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blinded assesment of wound healing at day 18-20. | Two indenpendent trained clinical doctors will evaluate clinical photos. Wounds will be evaluated fully epithelialized yes/no. | Day 18-20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blinded assesment of wound healing at day 11-13 | Clinical photos from day 11-13 will be evaluated. Wounds will be evaluated 50% fully epithelialized yes/no. | day 11-13 | 
| TEWL measurement | Trans epidermal water loss (TEWL) will be meassured at day 11-13 and day 18-20. The TEWL will be meassured on the wound healing site and the contralateral site of the patient's face as a control. | day 11-13 and day 18-20 | 
| Scar evaluation using the patient-observer-scar-assesment-scale (POSAS) at 6 months follow-up. | The POSAS observer scores scar components with regards to: Vascularity, pigmentation, thickness, surface area, relief and pliability. The collected sum of scores will range from minimum 6 points to maximum 60 points. | 6 months | 
| Difference in microbiology between intervention wounds and control wounds. | Swab test for microbiome analysis will be conducted at day 1 and day 11-13. | day 1 and day 11-13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MMS, Skin Cancer, Basal Cell Carcinoma, Mohs micrographic surgery, Autologous patch, Secondary intention healing