Epicel patient registry and repository agreement
B
Brett Hartman
Primary Investigator
Not Recruiting
100 years or below
All
Phase
N/A
4 participants needed
2 Locations
Brief description of study
The objective of the Epicel Registry is to allow the collection of demographic, treatment, and outcome data for future analyses regarding the real-world use of Epicel.
Detailed description of study
Epicel® (cultured epidermal autografts) is a permanent skin replacement indicated for use in adults and children who have deep dermal or full thickness burns covering a total body surface area greater than or equal to 30%. Epicel is made from the patient's own cells after they have grown for a period of time in an incubator. The Epicel graft replaces the epidermal or top layer of skin. This layer of skin is required to close or heal wounds. Epicel has been used to treat severely burned patients in the United States (US) and internationally since 1988, and was approved in the United States in 2007. Treatment with Epicel is not considered research.
The purpose of this study is to collect information and enter it into a registry database from records that already exist such as participants' medical records, the Epicel biopsy transmittal notice, and the Epicel Medical Device Tracking information. Information will be collected from the time of the participant's burn until 6 months after they leave the hospital.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Burn, graft
-
Age: 100 years or below
-
Gender: All
Inclusion Criteria:
- Participants who can provide informed consent
- Patients who receive Epicel skin grafts as part of their clinical care
- Additional criteria may apply. The study team will make a final determination of eligibility.
Exclusion Criteria:
Updated on
01 Aug 2024.
Study ID: 2004499970, SURG-VERICEL-EPICEL
