Sperry Micro-Coring System: Automated Full-Thickness Skin Microcolumns in Dermal Regeneration Templates for 'Donor-Free' Skin Renewal

Study Overview
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Brief Summary
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The objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (FTSMs) into a dermal regeneration template as coverage for open wounds without creating an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.

Detailed Description
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After enrollment and completion of informed consent, the patient will be considered an enrolled patient. Up to 10 patients with open wounds of the torso or extremities requiring skin grafting will be enrolled into this study. The study area will be 25 to 100 cm2. If a patient has multiple non-contiguous wounds that qualify for the study, up to two areas may be enrolled into the study. All other non-study areas will be treated per standard of care procedures/per the operating physician's discretion. The FTSMs will be harvested under sterile conditions in the operating room with a 1.5mm standard biopsy punch from a donor site deemed appropriate by the operating physician based on available healthy tissue; most commonly, the site is located on the thigh. Donor site location and rationale for this decision will be documented. Following FTSM harvest, they will be manually implanted into Integra® by experienced study personnel in the operating room. Using forceps, the FTSM will be inserted epidermis side up through the dermal regeneration matrix side with the silicone side being left in place. The FTSM within the dermal regeneration template will then be applied to the open wound and covered with a non-occlusive dressing. Additional secondary dressings of the physician's choice will also be utilized. Wounds will be assessed at the first dressing takedown while hospitalized by the subjects' medical teams and study members. Study members will be notified by hospital staff of any concerns including but not limited to infection, increased pain, or wound break-down. Study members will assess wounds at least once weekly for one month.

Official Title
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Sperry Micro-Coring System: Automated Full-Thickness Skin Microcolumns in Dermal Regeneration Templates for 'Donor-Free' Skin Renewal

Conditions
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Wound of Skin, Burns

Intervention / Treatment
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* Procedure: Full-thickness skin microcolumns implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8-85 years of age 15-100 cm2 open wound on the torso or extremities necessitating tissue coverage Sufficiently healthy skin to serve as a donor site Exclusion Criteria: Wound area involving the face* Wound area involving joints* Pregnancy Prisoner Active wound infection at potential treatment sites Exposed muscle, joint, tendon, or bone within the wound bed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Interventional Model Description: Proof of concept
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full-thickness skin microcolumns Implantation<br>implantation of FTSM on open wound | Procedure: Full-thickness skin microcolumns implantation<br>* Surgical harvest and implantation of FTSM on an open wound requiring coverage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor site re-epithelialization (primary endpoint) | donor site healing measured by re-epithelization | Between Day 10-14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor Site Healing | Assessment of donor site healing progression demonstrated by measurements of pigmentation, contraction, scar thickness. Parameters measured using Patient and Observer Scar Assessment Scale. The Patient and Observer Scar Assessment scale uses a 0-10 scale 0 being normal appearance, 10 being the worst possible outcome. | up to 6 months post treatment | 
| Treatment site healing | Assessment of treatment site healing progression demonstrated by measurements of pigmentation, contraction, scar thickness. Parameters measured using Patient and Observer Scar Assessment Scale. The Patient and Observer Scar Assessment scale uses a 0-10 scale 0 being normal appearance, 10 being the worst possible outcome. | up to 6 months post treatment | 
| Donor site pain | Assessment of donor site pain measured using the Visual Analog Scale. The Visual Analog scale uses a 0-10 scale 0 being no pain, 10 being the worst possible pain. | Up to 6 months post treatment | 
| Treatment site pain | Assessment of treatment site pain measured using the Visual Analog Scale. The Visual Analog scale uses a 0-10 scale 0 being no pain, 10 being the worst possible pain. | Up to 6 months post treatment |