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American Burn Association Clinical Trials Group (Meeting # 2)
Hyatt Regency, Chicago, Illinois
Start Date / Time: Saturday, April 27, 2002 3:30 PM
End Date / Time: Saturday, April 27, 2002 6:00 PM
Duration: 2 hours 30 minutes

Attendees

Jeffrey Saffle, Gary Purdue, Joel Fish, Nathan Kemalyan, Tina Palmieri, Bruce Cairns, John Hunt, Mark Klein, Charles Yowler, David Mozingo, Linda Edelman, Lorraine Donelson, Petra Warner, David Greenhalgh, Barbara Latensor, Paul Silverstein, Bill Mohr, James Cross, Steve Wolf, Lynn Solem, Cleon Goodwin, Johanna Sanders, Paul Edwards

Overview of the last year, Jeffrey Saffle MD

Discussion: Dr. Saffle welcomed attendees and reviewed accomplishments of the past year.

  1. Dr. Tina Palmieri, retrospective TENS review published in the JBCR
  2. Dr. Petra Warner, Purpura fulminans retrospective review abstract presented at 2002 ABA
  3. Oxandrolone study in process

Oxandrolone study report, Steve Wolf MD, Linda Edelman RN, MPhil

Discussion: The Oxandrolone study is currently in process. Dr. Steve Wolf is the principal investigator and Linda Edelman is the study coordinator. At this time, 28 patients from 9 sites have been enrolled. A total of 13 sites have received IRB approval to participate in the study. No unanticipated complications have occurred. An interim analysis will be performed after 75 patients have completed the study. Several other sites expressed interest in the study. Linda will email them study information.

Funding Possibilities

Discussion: Funding for the group was discussed.

  1. It was agreed that an infrastructure for the group should be established.
    • There was discussion about the need for an administrative office from which a series of multi-center trials could be run. Individuals were encouraged to look at funding and consider possibilities for establishing such an office at their institution.
  2. Potential funding sources for establishing an administrative office included:
    • NIH/NIGMS
    • Private foundations
    • FEMA
    • Health foundations such as the Northwest Health Foundation in Oregon which has funded over 3 million dollars in research per year
    • Gifts from industry
    • IAFF – fund small grants but may be able to apply for more than $25,000. Dr. Wolf will investigate possibilities.
    • Group members will individually look for funding sources and report to the group at the midyear meeting.

Future Studies

Discussion: A number of potential studies were discussed:

  1. Pediatric Oxandrolone study – Nathan Kemalyan
  2. IV-IG in TENS – Joel Fish
  3. DVT prophylaxis –
    • determined to be too large of a study to perform at this time because of the number of patients needed
  4. Longitudinal Quality of Life – Tina Palmieri
    • Patients stratified by age and burn size
  5. Retrospective review of burns in the frail elderly
  6. Impact of Necrotizing Fasciitis – Nathan Kemalyan
    • Retrospective review to establish best practice guidelines and impact of HBO, Integra, VAC
  7. Large burn resuscitation – Bruce Cairns*
    • Has sent a survey about resuscitation practices to burn centers across country, encouraged attendees to complete
    • A recent Annals paper reported that albumin had no effect on mortality
    • It would be difficult to agree on a protocol
  8. Abdominal Compartment Syndrome
  9. VDR survey
  10. In-line hemodynamic monitoring – Bruce Cairns
    • Doesn’t require a PA line
    • FDA approved
    • Easy to use
  11. H-2 blockers
    • Are they really needed?
  12. Transfusion study – Tina Palmieri*
    • Randomized study
    • One group not to be transfused until Hct 21 or lower
  13. Ventilator associated pneumonias
    • Inhaled aminoglycosides (prophylaxis versus treatment)

* At this time, Dr. Cairns will continue with his fluid resuscitation survey and Dr. Palmieri will begin writing a protocol for a transfusion study.

Attendees will submit short protocols for the above mentioned or other studies for consideration by the group at the mid-year meeting in August.

Next Meeting

Discussion: The Mid-year Meeting will be held during the International Society for Burn Injuries Meeting August 13-15, 2002 in Seattle, WA. Participants with future study ideas should submit short study protocols to Dr. Saffle for consideration at this meeting. The meeting will be Friday August 16 from 12:00-4:00. Lunch will be served.