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Comprehensive CSS MOrley Audit Report_25MAR2010[1]

Comprehensive CSS MOrley Audit Report_25MAR2010[1]

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Published by: Sandy Frost on Sep 04, 2014
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Comprehensive Audit Report Protocol: Burn Wound Repair with Cultured Skin Substitute IDE Number: G980023
Conducted by: The Walter B. Morley Research Foundation January 2009- December 2009
Table of Contents: Page:
1.
 
Demographics/ Subject Status Summary 3 2.
 
Informed Consent 7 3.
 
Compassionate Use 12 4.
 
Case Report Form Summary 15 5.
 
Subject Eligibility 19 6.
 
Randomization/ Wound Site Selection 23 7.
 
Pre Treatment of Study Sites 29 8.
 
Burn Area Estimates 33 9.
 
Summary-Pre-Study Visit 36 10.
 
Pre-Study Medical History 37 11.
 
Pre-Study Physical Exam 38 12.
 
Pre-Study Serum Antibodies 39 13.
 
Pre- Study Skin Biopsy for Tracing 40 14.
 
CSS Tracings in Vitro 41 15.
 
P
ost Operative Date Completion For All Sets 42 16.
 
Biopsy of Recipient Sites 46 17.
 
Photography of Wound Bed/ Pre-Surgery 47 18.
 
Photography Post Graph 48 19.
 
Study Site Tracings for POD 14/ POD 28 49 20.
 
Microbial Cultures 51 21.
 
Healed Wound Biopsy 52 22.
 
Healed Area/ Donor Area Ratio 53 23.
 
% Engraftment Completed for POD 14 55 24.
 
% Engraftment Completed for POD 28 56
 
2
25.
 
Physical Exam Conducted at POD 0 57 26.
 
Physical Exam Conducted at POD 28 58 27.
 
Serum For Antibodies Completed for POD 28 59 28.
 
Investigator Global Assessment 60 29.
 
Qualitative Outcome 62 30.
 
Adverse Event Summary for POD 14/28 68 31.
 
Cultured Skin Substitute Wound Care 70 32.
 
Unanticipated Adverse Devices Effects/Serious 76 Adverse Events/ Event Reporting 33.
 
Concomitant Medications 96 34.
 
Abnormal Laboratory Values 111 35.
 
Primary Study Endpoints 112 36.
 
Secondary Study Endpoints 116 37.
 
Device Quality Assurance Testing/ Sterility Testing 120 38.
 
Device Returned 122 39.
 
Device Labeling/Device Storage 124 40.
 
Device Disposal 126 41.
 
Device Shipping Information Available 128 42.
 
Protocol Deviation Summary 130 43.
 
Protocol Deviation Reported to IRB 131 44.
 
Protocol Deviations Reported To Sponsor 133 45.
 
Sample Audit of the First 81 Subjects in the CSS Study 134 46.
 
Annual Reports 135
 
47.
 
Standard Operating Procedures (SOPs) Review 145 48.
 
System Audit Conundrums 146 49.
 
The Morley Research Foundation Interview Report 146 For Physicians and Nurses Involved in the CSS Clinical Trial 50.
 
Data Safety Monitoring Board (DSMB) Report 150 Audit of Regulatory and Institutional Review Board 163
 Appendix A: Various Versions of Qualitative Outcome
197
Case Report Forms  Appendix B: Listing of Adverse Events
200
 Appendix C: Investigator Global Assessment Case Report Forms
201
 Appendix D: Copy Device Label Provided to Auditors
202
 Appendix E: Safety Monitoring Procedure
203
 Appendix F: Conflict of Interest Statement
205
 Appendix G: Article “Medical Advances Incubate in Corryville” 
 
207
 
3
1.
 
Demographics/ Subject Status Summary
The demographics for the subjects of the Cultured Skin Study were captured on the case report forms for general use. There were no restrictions per the protocol for age, gender, or race. Figure 1.1 (below) illustrates that the ages for the study participants ranged from a few months old up to 27 years old. As shown in figure 1.2, the overall gender of the study audit population was male. Males were shown to  be five times more likely to be a burn patient with respect to the make-up of this study. The breakdown for race, shown in Figure 1.4, indicates that the majority of subjects were Caucasian, closely followed by Hispanic, then few numbers for African American and others. Per figure 1.3, the majority of study subjects were enrolled by the Cincinnati Shriners site, followed by Galveston Shriners, then the Sacramento Shriners, with one subject enrolled at the Boston Shriners site. The questions that evolved from the enrollment of these outlying sites will be addressed within the specific section where the question occurred.

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