July 17, 2001 GPS Panel Meeting
1. Adverse events such as pain, infection, and itching were similar in the clinical study for both the CCS and the Biobrane-L (BIO) control. Please discuss whether the safety data for CCS provides a reasonable assurance that it is safe for the management of split thickness autograft donor sites in burn patients.
2. The primary effectiveness endpoint in the protocol was time to complete wound closure as measured by photographic assessment. The study was designed to evaluate a 9.5-day improvement in time to wound closure. The primary efficacy results are provided in the following table:
Median Days to Wound Closure Mean Days to Wound Closure
CCS BIO p-value CCS BIO p-value
Photographic ITT 15.0 22.0 0.0006 18.0 22.4 <0.0001
Photographic PP 15.0 21.0 0.0009 17.8 22.1 <0.0001
Investigator ITT 12.0 16.0 <0.0001 13.2 18.4 <0.0001
Investigator PP 12.0 16.0 <0.0001 12.9 17.9 <0.0001
Do these data demonstrate that there is a reasonable assurance that in a significant portion of the target population, the use of CCS will provide clinically significant results?
3. Do you have any recommendations regarding the proposed labeling including indications, contraindications, warnings, precautions, instructions for use, etc.?