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

LifeBridge Health

Status

Withdrawn

Conditions

Wounds and Injuries

Treatments

Procedure: Split Thickness Skin Graft

Device: Cellutome Epidermal Harvesting System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02492048

2199

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.