ABA Multicenter Trials Group
Town Hall Meeting
American Burn Association Annual Meeting
San Antonio TX
March 25, 2008

Overview and welcome – J Saffle

1. Welcome

2. Overview of MCTG structure

a. Steering committee
b. Subcommittees

3. Change to ABA ByLaws to make the MCTG a standing committee of the ABA

a. MCTG will retain structure
b. ByLaws and Policies and Procedures will remain in effect

4. Director of research operations (DROP) hired

a. Mary Beth Lawless RN

5. Data collection center

a. Negotiations in process
b. University of California Davis

6. Funding

a. Now have funding for infrastructure and several studies
b. Ongoing projects

i. Trigger study – T Palmieri
ii. Rehab study – R Richards

- Sites obtained

iii. ReCell Device – J Holmes

- 10 centers
- Sites obtained
- ARM funding

iv. Glutamine – P Wischmeyer

- Funding by Canadian govt
- We will support another 100 additional patients
- Looking for sites

v. Extended duration silver dressing – L Cancio

- Funded
- Looking for sites

vi. Abdominal Compartment Syndrome – B Latenser

- Ongoing

c. US Army proposals

i. Review Process

- 11/2008

All ABA members notified that the Army had identified 4 topics that they were interested in funding for burn research

1. Renal replacement
2. Utilizaiton of presumptive antibiotics
3. Metabolic manipulation
4. Improving diagnosis of Inhalation Injury

- 12/15/2008
Received 26 prepropsals

- 12/30/2008
12 finalists selected
Reviewed by Sub Committees

- 3/5/2009
5 selected

1. High volume hemofiltration – Chung
Looking for 10 centers

2. Development of an inhalation injury scoring system – Foster
Non interventional

3. Effects of enteral glutamine – Wischmeyer

4. PCR-based detection of Staph aureus - Tran

5. Community based exercise program – Suman
2 centers selected

7. Steering committee membership

a. Jeff Saffle is rotating off as president
b. Accepting nominations
c. Tina Palmieri will be in charge of running nominations and elections

i. Voting will be via web site

Presentation of studies

1. Burn Outcomes Research Infrastructure Grant Update – T Palmieri

a. Created from legislative efforts in DC

i. Barbara Boxer dedicated to burned soldier’s care
ii. Additional support from representatives in CA
iii. Signed off by President Bush in 2008
iv. Money has been obligated but not deligated
v. Must go through the DOD to put in the full-proposal

- Very specific instructions on how to do this

vi. After this proposal is approved must go through 3rd review process

b. Will provide for center for data collection

i. Help with IRB
ii. Statistical support
iii. Revision, classification of proposals

c. Goal : Develop a system for a data validation/analysis for outcomes from the NBR

i. Profile burn care outcomes
ii. Describe variability in factors on outcomes
iii. Develop a predictive model adjusted over time to estimate outcomes

- Non-changeable factors
- Changeable Factors

d. Funding in October 2009

2. Blood transfusion study update - T Palmieri

a. All proposals written, submitted to military IRB

i. Just approved today! (March 25, 2009)

b. Award letter for $2.4 million in October 2008

c. Site selection evaluation paperwork sent to all centers

d. Initial 12 centers selected

e. First investigator meeting in January 2009

f. Second meeting this last Monday

g. 2 quarterly reports sent so far

h. DROP in place

i. Development of informatics and biostatistics infrastructure for further studies underway

j. Going through the final design process (agreeing on variables and data definitions)

k. Burn patient acuity demographics, scar contractures and rehabilitation treatment time related to patient outcomes (ACT) – Reg Richards

l. Purpose:

i. Look at rehabilitation processes
ii. Establish a database of clinical parameters
iii. Focus on rehabilitation treatment time

m. Sites selected across US (19)

n. Methods

i. Prospective data collection
ii. 27 domains

- Over 3 time periods

1. Admission
2. Daily hospital (time of therapy)
3. Discharge

- Using SAGE program

1. Subdividing down to functional units
i. Ie., Hand representing 100% of itself

- Using UC Davis Velos data collection system

1. Trying to merge the two

o. Renumerations

i. Renumeration depends on burn size

- For example: 1-10% TBSA (n=400) $700 for complete data

p. Status

i. Awaiting IRB approval

- Approved by BAMC

- Debate over waiver of consent

ii. Developing computerized data collection platform

- Modification of Sage Diagram
- UC Davis DCC electronic data forms

iii. Developing computerized data collection platform

iv. Trialing time collection form @ISR

- Beginning next month

v. Development of SOP for other centers to use

vi. Begin enrollment at other centers

3. Albumin study – B Cairns

a. Goal was to evaluate whether study of albumin was possible
b. Developed a survey
c. Conducted a retrospective/prospective study

i. 458 patients
ii. 12 centers
iii. In data analysis

- Would like DCC help
- Will use results to propose a prospective clinical trial

d. A study to evaluate the effectiveness of Milliken’s SelectSilver Anticmicrobial dressing in the treatment of burns– L Cancio

e. Funded

i. Congressional appropriation

- Managed through US Army Research

ii. Not a US Army funded protocol
iii. Dr. Cancio’s role is to coordinate

f. Enlisting centers

i. 4-6 sites

g. SelectSilver

i. Manufactured by Milliken’s

- Millikens is not funded
- Dr. Cancio will control study and data

ii. FDA approved
iii. Improved fluid management (too much or too little fluid on wound surface)

h. Purpose

i. To determine efficacy comparing to standard post-op dressing (Sulfamyelon)
ii. Small burns

i. Primary endpoint

i. Time to 95% epithelialization

j. Secondary endpoints

i. Ease of use, pain

k. Contact lee.cancio@us.army.mil

4. DVT – M Peck

a. Protocol being revised
b. Meet today after this meeting
c. Looking for sites

5. Blood transfusion study update - T Palmieri

a. Retrospective review of fluid creep – L Wibbenmeyer
b. Correlation with opioid use
c. Reasons why it occurs
d. Looking for 15 plus centers
e. Database developed
f. On website
g. Two page data collection form

6. Use of narcotics in burn patients – L Wibbenmeyer

a. Opioids associated with immunsuppression and fluid creep
b. Information on website

7. Iron saturation - G Lindberg

a. 3 groups
b. Iron, Iron + epo, No Iron
c. Will put on website

How do centers propose studies?

1. If want MCTG help in creating a protocol

a. Look at Policy and Procedures manual for protocol
b. Will have a form on the website for centers to complete

i. Number of beds
ii. IRB
iii. Contact information
iv. Number of admissions, etc.
v. This form will be posted after the ABA on the website

c. Contact Jeff Saffle, Tina Palmieri, or Linda Edelman to place a study on the website

d. Individuals must update email on ABA website in order to receive MCTG notices

Nomination to replace Dr. Saffle

1. Call for nominations

a. Jeffrey Saffle (by Steve Wolf)
b. Seconded by L. Cancio
c. Chair of the steering committee is chosen by steering committee election

2. An election to retain Dr. Saffle will be held via the MCTG web page within the next few weeks.

Submitted by Linda S. Edelman 3/30/09
Linda.edelman@nurs.utah.edu