Dermal Micrografts in Regenerative Surgery

Study Overview
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Brief Summary
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Objective assessment of the effectiveness of a micro-fragmented dermal extract obtained with Rigenera™ technology (patented by Human Brain Wave) in promoting the wound healing process in an in-vivo homogeneous experimental human acute surgical wound model.

Detailed Description
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The aim of the study is the objective assessment of the effectiveness of a micro-fragmented dermal extract obtained with Rigenera™ technology (patented by Human Brain Wave) in promoting the wound healing process in an in-vivo homogeneous experimental human acute surgical wound model. The study includes 20 patients with 24 acute post-surgical soft tissue loss and a planned sequential two-stage repair with dermal substitute and autologous split-thickness skin graft. Each acute post-surgical soft tissue loss is randomized to be treated either with Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with Rigenera™ technology (group A - Rigenera™ protocol) or with Integra® dermal substitute only (group B - Control). The re-epithelialization rate in the wounds is assessed in both groups at 4 weeks through digital photography with the software Image J. The dermal cell suspension enrichment with the Rigenera™ technology is considered effective if the re-epithelialized area is higher than the 25% of the total wound surface as this threshold is considered far beyond the expected spontaneous re-epithelialization rate.

Official Title
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Role of Autologous Dermal Micrografts in Regenerative Surgery

Conditions
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Regenerative Medicine

Intervention / Treatment
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* Procedure: Integra® dermal substitute and RigeneraTM protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-surgical defect in any site of the body with a size range 4-400 cm2. Exclusion Criteria: Wound infection, chemotherapy in the last 6 months, use of corticosteroids or immunosuppressive treatment, metabolic, endocrine, autoimmune and collagen diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 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: The study includes 20 patients with 24 post-surgical defect in any site of the body with a size range 4-400 cm2. The acute post-surgical soft tissue loss is considered the experimental unit of the study irrespective of the number of wounds per patient. Each unit is randomized to be treated either with Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol (group A - RigeneraTM protocol - 12 units) or with Integra® dermal substitute only (group B - Control - 12 units). The expected endpoint is a spontaneous re-epithelialization higher than 25% of the total wound area in group A at 4 weeks. The secondary endpoint is the comparison of the re-epithelialization rate at 4 weeks after the first surgical stage between the group A and the controls. The re-epithelialization rate in the wounds is assessed through digital photography with the software Image J.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RigeneraTM protocol<br>Teatment with Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol. | Procedure: Integra® dermal substitute and RigeneraTM protocol<br>* Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol<br>|
| Experimental: Control<br>Treatment with Integra® dermal substitute only. | Procedure: Integra® dermal substitute and RigeneraTM protocol<br>* Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous re-epithelialization. | Percentage of patients with spontaneous re-epithelialization of the total wound surface higher than 25% as assessed by Image J Software | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cell transplants, Autografting