SPECIAL NOTICE
A -- Request for Information: Care and Treatment for Burn Patients
- Notice Date
- 8/24/2011
- Notice Type
- Special Notice
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-RFI-BURN
- Archive Date
- 11/22/2011
- Point of Contact
- Mary C. Rico, 301-619-8669
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(mary.rico@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Request for Information: Care and Treatment for Burn Patients Key Dates Release Date: 24 AUG, 2011 Response Date: 23 SEP, 2011 Issued by The Joint Program Committee-6, United States Army Medical Research and Materiel Command Background The Joint Program Committee-6 was established by the Defense Health Program of the Department of Defense to provide guidance to the research community focused on Combat Casualty Care research. They are interested in all areas of care that will benefit the warfighter that is injured in combat operations. At this time, the JPC-6 Committee is interested in obtaining information on optimizing the treatment, recovery and restoration of function for military personnel that sustain burn injuries while serving actively in the combat theater of operation, or while performing non-combat related duties. The JPC-6 is considering offering a program announcement for specific areas and is issuing this RFI to assess available and/or emerging capabilities that have the potential to address the following areas of interest: AMulti-center development and assessment of the impact of checklists on standardization of burn care and improvement of outcomes in burn patients. The care of burn patients is complex, and the providers delivering this care must manage many tasks. If these tasks are missed or not performed correctly, then patient care may not be optimal. In other sectors, and in other health care specialties, the use of checklists to manage critical tasks has proven useful and beneficial on outcomes. Studies to develop, implement and document the utility or lack of utility of checklists in the burn critical care environment are required. BMulticenter studies of ICU-based rehabilitation outcomes, i.e., evaluation of physical and rehabilitation technologies/therapies directed at (1) short-term ICU outcomes (decreasing ICU length of stay and ventilator days); (2) understanding the effect of rehabilitation on pathophysiology in the ICU burn patient; and (3) documenting the efficacy of these immediate ICU interventions on long-term quality-of-life outcomes such as the return-to-work/duty rate The combination of severe injury, prolonged bedrest, and mechanical ventilation causes dramatic changes in human physiology. Whereas rehabilitation was traditionally viewed as a later "phase" following resuscitation and surgical care, now we recognize that to be effective it must begin on admission and continue throughout inpatient and outpatient care. Little is known, however, about the impact which timely and aggressive rehabilitation may have on outcomes like ventilator days, ICU days, and physical conditioning while the patient is still in the ICU. Further, the impact which immediate ICU rehabilitation may have on long term outcomes is also poorly documented. CDevice/drug development and validation for inhalation lung injury The combination of inhalation injury and burns results in mortality rates that far exceed the rate for burns alone. Development of a device that would provide Extracorporeal Lung Support (or other devices/drugs for the treatment of severe inhalation injury) has the potential to address this issue by allowing the lungs to recover while respiratory demand is partially or fully met. Furthermore, extracorporeal lung support devices need to be reduced in weight, size, oxygen requirements, and complexity. The desired end state a device which (1) can be employed at the level III / Combat Support Hospital and during En Route Care, and (2) can be used by a variety of personnel with little to no prior experience with such technologies (Emergency Physicians, ICU nurses, General Surgeons, Intensivists) D.Evaluation of devices/therapies for increasing burn wound healing and/or graft healing rates The burn patient remains at high risk for complications until all wounds either re-epithelialize or are covered with skin grafts. Evaluation of devices or therapies to accelerate or improve the quality of wound healing in these wounds would be of value. Of highest value are studies that directly compare devices and therapies in order to provide clinicians an evidence base to support clinical decision making Information Requested To respond to this RFI, please address the following questions. It is requested that each response address a single focus area. If you would like to comment on multiple focus areas, you are encouraged to submit multiple responses. 1) What novel approaches are you aware of that meet the individual focus areas described above? Where are they in their level of development, e.g., basic research, pre-clinical, or clinical validation? Please describe any relevant research/products of which you are aware, with brief details about each therapeutic pharmaceutical/device and its intended intervention, and the stage of clinical development in progress. Please also include any information on Investigational New Drug or Investigational Device Exemption applications with the FDA. 2) What novel approaches that meet the above focus areas are in pre-clinical stages of development? Briefly describe each relevant approach, including status of any animal or observational/clinical validation, technology development, and manufacturing progress. Estimate time needed for additional research and development before clinical trial readiness. Response and Process To facilitate review of responses, please clearly mark which of the above focus areas is relevant to the response. Please respond no later than 23 SEP 2011. Responses should be limited to 500 words or less, and should be submitted to nita.grimsley@us.army.mil. Please use "RFI Response" in the subject line. Telephone calls will not be accepted. This RFI is issued solely for information and planning purposes and does not constitute a solicitation or issuance thereof. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to this RFI will not be returned. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract or award. Responders are solely responsible for all expenses associated with responding to this RFI.
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- Record
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