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.?