Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients

Study Overview
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Brief Summary
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This is multi-center prospective, longitudinal case series with comparison to historical controls.

Detailed Description
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The primary objective to this study is to determine the effectiveness of CelluTome™ epidermal harvesting system as an outpatient skin grafting system for selected patients versus inpatient skin graft harvest. This is multi-center prospective, longitudinal case series with comparison to historical controls. In this study, all subjects will receive the same treatment protocol regardless of institution. This will include routine wound photography. Ongoing healing process will be recorded and reviewed. The secondary objectives of this study are to establish an ideal donor site size, recipient site size and ideal patient population (especially high operative risk patients) that would benefit from the use of CelluTome™ Epidermal Harvesting System.

Official Title
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Effectiveness of CelluTome Epidermal Harvesting System in Autologous Skin Grafting of Chronic Wound Patients

Conditions
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Wounds and Injuries

Intervention / Treatment
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* Device: Cellutome Epidermal Harvesting System
* Procedure: Split Thickness Skin Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Patients requiring split-thickness skin grafting with non-infected wounds Age of participants: 18 years and above at the time of informed consent Gender: Male or Female Subjects who will be locally available for the next 6 months. Exclusion Criteria: Infected chronic wound Patients who are unable to adhere to scheduled study visits Patients who have severe arterial insufficiency requiring vascular intervention to restore adequate blood flow Patients who have an active drug/alcohol dependence or abuse history Use of Investigational Agents/Devices on study or within 30 days prior to informed consent or within 30 days prior to use of device.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Split Thickness Skin Graft Harvest<br>Retrospective review | Procedure: Split Thickness Skin Graft<br>* Split Thickness Skin Graft<br>|
| Experimental: Cellutome Epidermal Harvesting System<br>Prospective patients will receive a skin graft utilizing the Cellutome Epidermal Harvesting System | Device: Cellutome Epidermal Harvesting System<br>* Cellutome Epidermal Harvesting System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing Time | Healing time is defined as the required time for the graft site to become dry enough for removal of the dressing without further discharge from the wound AND 100% re-epithelialization has occurred | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing at Donor Site | Photography and physician examination with determination | 8 weeks | 
| Scarring | Areas of donor site which heal with excess scar tissue and recipient site which heal due to secondary intention (epithelization without skin grafting application). Photography and physician examination with determination. | 8 weeks | 
| Complications | Cellulitis involving the donor or recipient site, infection involving continuous drainage, abscess formation, erythema, edema, pruritus and fever. Physician determination of complications post procedure. | 8 weeks |