Panel Questions

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.?