NCT02492048

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: LifeBridge Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wounds and Injuries

Interventions

Type	Name	Description
DEVICE	Cellutome Epidermal Harvesting System	Cellutome Epidermal Harvesting System
PROCEDURE	Split Thickness Skin Graft	Split Thickness Skin Graft

Timeline

• Start date: 2014-12-16
• Primary completion: 2016-11-22
• Completion: 2018-12-01
• First posted: 2015-07-08
• Last updated: 2018-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study