Clinical trial NCT02992249: Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Lead sponsor: Avita Medical
Sponsor class: INDUSTRY
First posted: 2016-12-14
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* The patient requires treatment of a life-threatening wound requiring grafting.
* Patient has inadequate available skin to harvest for conventional skin grafting.
* The treating investigator has determined 1) that there is no suitable alternative therapy that would be adequate to meet the patient's medical need; and 2) the risk associated with use of the ReCell device is no greater than the probable risk from the disease or condition.
* In the treating investigator's opinion and with consideration of the severity of the patient's health status, the patient has the potential to realize benefits from the application of the ReCell device.
* Patient is hemodynamically stable.
* The patient (or legal representative) is able to read and understand instructions and give informed consent.

Exclusion Criteria:

* The patient has active infection at the proposed ReCell treatment site.
* The patient is unable to follow the protocol.
* The patient has a known hypersensitivity to trypsin or Compound Sodium Lactate for Irrigation (Hartmann's) solution.

Primary outcomes:
measure: Wound Healing
timeFrame: Wound healing assessed at all study visits
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Department of Surgery
state: Alabama
city: Phoenix
country: United States
facility: Arizona Burn Center at Maricopa Integrated Health Systems
state: Arizona
city: San Diego
country: United States
facility: University of California San Diego Regional Burn Center
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Augusta
country: United States
facility: Joseph M Still Research Foundation
state: Georgia
city: Indianapolis
country: United States
facility: Richard M. Fairbanks Burn Center at Eskenazi Health
state: Indiana
city: Baton Rouge
country: United States
facility: Baton Rouge General Regional Burn Center
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center Bethesda
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Shriner's Boston
state: Massachusetts
city: Jackson
country: United States
facility: MS Burn & Reconstruction Center, Merit Health Central
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
city: Springfield
country: United States
facility: Mercy General Burn Center - Springfield
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: U.S.Army Institute of Surgical Research
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
References: