Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective uncontrolled observational study to evaluate clinical outcomes following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting for closure, and associated skin graft donor sites, in patients who lack adequate available skin to harvest for conventional grafting. Treatment with the ReCell device may be performed as part of a single operative procedure, or multiple staged procedures as deemed clinically necessary. Adverse events associated with the use of the ReCell device/cell suspension will be documented. Subjects will be followed for 1 year following ReCell treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing | > 95% epithelialization with a contiguous layer of viable epithelium | Wound healing assessed at all study visits |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
This is a prospective uncontrolled observational study to evaluate clinical outcomes following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for closure (re-epithelialization) as a treatment of life-threatening wounds requiring grafting for closure, and associated skin graft donor sites, in patients who lack adequate available skin to harvest for conventional grafting.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Department of Surgery | Mobile | Alabama | 36688 | United States | ||
| Arizona Burn Center at Maricopa Integrated Health Systems |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Phoenix |
| Arizona |
| 85008 |
| United States |
| University of California San Diego Regional Burn Center | San Diego | California | 92103-8896 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States |
| Joseph M Still Research Foundation | Augusta | Georgia | 30909 | United States |
| Richard M. Fairbanks Burn Center at Eskenazi Health | Indianapolis | Indiana | 46202 | United States |
| Baton Rouge General Regional Burn Center | Baton Rouge | Louisiana | 70809 | United States |
| University Medical Center | New Orleans | Louisiana | 70112 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Walter Reed National Military Medical Center Bethesda | Bethesda | Maryland | 20889 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Shriner's Boston | Boston | Massachusetts | 02114 | United States |
| MS Burn & Reconstruction Center, Merit Health Central | Jackson | Mississippi | 39204 | United States |
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
| Children's Mercy Kansas City | Kansas City | Missouri | 64108 | United States |
| Mercy General Burn Center - Springfield | Springfield | Missouri | 65804 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38103-3409 | United States |
| U.S.Army Institute of Surgical Research | Fort Sam Houston | Texas | 78234-7767 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided