Do you have a skin injury that needs a skin graft? Conditions such as:
Skin Graft or Auto Graft
Surgical Wound Treatment
Soft Tissue Injury
Scar Revision Requiring Skin Graft
Full Thickness Skin Defects
Abdominal Compartment Syndrome
You may be eligible to participate in the new RECELL® System clinical trial.
Phoenix, Arizona, United States, 85008
Contact: Karen Richey, RN, BSN
Phone: 602-344-5751 Email: [email protected]
Principal Investigator: Kevin N Foster, MD, MBA, FACS
United States, California
United States, Florida
United States, Illinois
Principal Investigator: Mark A Grevious, MD, MBA, FACS
United States, Louisiana
Principal Investigator: Herbert Phelan, MD
Durham, North Carolina, United States, 27710
Contact: Jennifer Gallagher
Phone: 540-905-0355 Email: [email protected]
Winston-Salem, North Carolina, United States, 27157
Contact: Renea Jennings, RN, BSN
Phone: 336-716-6709 Email: [email protected]
Phone: 336-713-4339 Email: [email protected]
Principal Investigator: Joseph A Molnar, MD, PhD
United States, Ohio
Pittsburgh, Pennsylvania, United States, 15213
Contact: Eleanor Shirley, MA
Phone: 412-383-7712 Email: [email protected]
Principal Investigator: J. Peter Rubin, MD, FACS
Corpus Christi, Texas, United States, 78411
Contact: Erin Richmond, MS, RN, CPHON, CCRP
Phone: 361-694-5978 Email: [email protected]
Principal Investigator: Kevin Hopkins, MD, FACS
Fort Worth, Texas, United States, 76104
Contact: Valentina Jovic
Phone: 817-702-1680 Email: [email protected]
Principal Investigator: Steven E Mapula, MD
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided above.
- The patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related).
- The maximum area requiring autografting is 50% Total Body Surface Area (TBSA).
- Two comparable areas requiring autografting, each at least 80 cm2 (or 160 cm2 contiguous), excluding face and genitalia. When hands or joints are included in the treatment areas, comparability of treatment areas means that each area (RECELL and Control) must include the same contralateral joint and/or hand.
- The patient is at least 5 years of age.
- The patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule.
- The patient agrees to abstain from any other treatment (e.g., external fixation) of the study treatment areas for the duration of his/her participation the study (1 year).
- The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year).
- In the opinion of the investigator, the patient and/or guardian must be able to:
- Understand the full nature and purpose of the study, including possible risks and adverse events,
- Understand instructions, and
- Provide voluntary informed written consent.
- Not able to understand English or Spanish.
- The area requiring autografting sustained a burn injury.
- The treatment area has previously failed to heal subsequent to surgical intervention for closure.
- The patient is unable to follow the protocol requirements.
- The patient has a condition that in the investigator’s opinion may compromise patient safety or trial objectives.
- Current use of medications that in the investigator’s opinion may compromise patient safety or trial objectives.
- The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann’s) solution.
- The patient is pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
- Life expectancy is less than 1 year.