Wounds and Injuries
Conditions
Brief summary
This is multi-center prospective, longitudinal case series with comparison to historical controls.
Detailed 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.
Interventions
Cellutome Epidermal Harvesting System
PROCEDURESplit Thickness Skin Graft
Split Thickness Skin Graft
Sponsors
Kinetic Concepts, Inc.
LifeBridge Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing Time | 8 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing at Donor Site | 8 weeks | Photography and physician examination with determination |
| Scarring | 8 weeks | 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. |
| Complications | 8 weeks | Cellulitis involving the donor or recipient site, infection involving continuous drainage, abscess formation, erythema, edema, pruritus and fever. Physician determination of complications post procedure. |
Countries
United States
Outcome results
None listed