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

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

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

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.

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.