21-03-Wound_Infections

Prevention of Combat Wound Infections

The Joint Program Committee (JPC)‐2/Military Infectious Diseases Research Program (MIDRP) is one of six major Defense Health Program (DHP) core research program areas within the DHP Medical Research Development Test & Evaluation (RDT&E). JPC‐2 is a committee of DoD and non‐ DoD medical and military technical experts in infectious disease‐related program areas. Per the MIDRP’s mission statement, JPC‐2/MIDRP seeks to plan, coordinate and oversee for the DoD, a focused and responsive world class infectious diseases Science and Technology (S&T) program, leading to fielding of effective, improved means of protection and treatment to maintain effective global operational capability by maximizing Warfighter readiness and performance.

 

Combat wound infections in a prolonged care environment are a major risk to Warfighter survivability and their ability to return to competition, posing a significant burden to an Army Health System that has little to no capacity for significant periods of time during Multi‐Domain Operations. Research has shown that greater than 30% of all combat wounds become infected. That percentage is expected to rise in a prolonged care environment, hence integrated interventions provided by Tactical Combat Casualty Care (TCCC) providers at the point of injury are critically important to diminish the occurrence of infection in battlefield wounds.

 

The goal of this RPP is to develop prototype solutions that enable prevention of Warfighter wound infections on the battlefield as close to the point of injury as possible without requiring evacuation to higher roles of care and to enable speedy return of Warfighters to duty. Therefore, this requirement is focused on a multi‐layered approach to protecting Warfighters against wound infections. The proposed solution(s) is expected to be part of a system to provide an adequate response to complex traumatic penetrating injuries that can lead to wound infections. An ideal solutions would meet the following requirements (not listed in order of importance):

 

  1. Broad and rapid microbicidal (bacterial and/or fungal) activity with a shelf life of at least a year. For proposed solutions that may have to be opened multiple times, it is preferred that the “use within” period is at least one year.
  2. Ease of use, small and lightweight (i.e., should fit in a combat medic’s medical bag) without the need for additional logistic considerations, e.g., cold/warm storage, impact protection, additional supplies/products to enable use.
  3. When placed into a wound, the product should not stain the skin or surrounding exposed underlying tissue and should be easily removable (i.e., washed out of the site of placement with sterile water or saline).
  4. The product should be usable and efficacious in austere environment conditions, as well as packaging that maintains integrity in wide temperature ranges, and also in conditions of high and low humidity.
  5. Demonstrable efficacious use of the product on the wound for at least three days in austere environmental conditions referenced above.

 

The research project award recipients were selected from the Offerors who responded to MTEC’s Request for Project Proposals (21-03-Wound_Infections).

 

Succor Combat Foam for Wound Infection Prevention

Project Team: Critical Innovations

Award Amount: $3.21M (additional cost share = $399K)

Project Duration: 25 months

Project Objective: The Succor Combat Foam for Wound Infection Prevention is a novel, easy-to-use, non‐surgical solution for moderate-to-severe penetrating wounds that prevents infection while providing temporizing tissue stabilization, to return the Warfighter to functional duty and avoid the need for immediate medical evacuation. This dual-use military and civilian device is easy to use at the point of injury, in the forward deployed environment, thru medical evacuation, and during prolonged field care (PFC). The patent-pending Succor is the world’s first foaming hydrogel that self-sets for medical use. This provides many of the benefits associated with other hydrogel products, while eliminating their associated problems and allowing delivery of therapeutics in very high local concentrations to large, dermally-disrupted surface areas. Succor comes in a lightweight and small-volume canister, making it particularly well-suited for use far forward use.

 

BIAKŌS™ Antimicrobial Wound Gel: Providing Combat Wound Infection Prevention and Treatment in a Prolonged Care Environment

Project Team: Rochal Industries

Award Amount: $1.98M

Project Duration: 24 months

Project Objective: Infections – on the battlefield, treatment facility-acquired, or secondary – contribute to delays in Warfighter ability to return to duty as well as mortality and morbidity following traumatic injuries. The proposed work intends to provide objective evidence that BIAKŌS Antimicrobial Wound Gel is an ideal solution that enables prevention of Warfighter wound infections on the battlefield when applied at the point of injury enabling a speedy recovery without evacuation to higher levels of care.

 

Prevention of Wound Infections at Point-of-Injury and in Pre-Hospital Environments

Project Team: Synedgen

Award Amount: $3.99M

Project Duration: 24 months

Project Objective: This project defines the development and regulatory efforts to reformulate and package a point-of-injury wound care topical treatment, SynEX, based on a proven, 510(k) cleared wound treatment, SynePure®. SynEX milestones will be to (i) reformulate and repackage the product to meet the requirements for far-forward use, (ii) validate that the new formulation retains equivalent or demonstrates enhanced properties in controlling broad-spectrum bacterial populations, and (iii) facilitates wound healing in a human clinical trial.

 

Bioresorbable Ultrathin Matrix Delivering Silver and Gallium to Wounds for Synergistic Killing of Biofilm for Prolonged Field Care

Project Team: Imbed Biosciences

Award Amount: $2.20M

Project Duration: 24 months

Project Objective: We have developed a novel ultrathin bioresorbable Microlyte Ag-Ga Matrix that contains silver and gallium, which act synergistically to kill not only a broad spectrum of planktonic bacteria and yeast but also mature biofilms. The product is easy to use, light weight, shelf stable, heat stable, sterile and provides antimicrobial activity for at least 3 days.

 

Amicidin-alpha Prolonged Field Care Product

Project Team: Amicrobe

Award Amount: $2.00M (additional cost share = $148K)

Project Duration: 25 months

Project Objective: Amicidin-alpha is a member of a new class of antimicrobials designed for direct application to exposed tissues of surgery and trauma. Built at the interface of materials science and biotechnology, Amicidin-alpha is a synthetic protein (MW ~21 kDa) composed of two amino acids, lysine and leucine, arranged in a diblock architecture: one positively charged hydrophilic segment and one hydrophobic segment. It has a dual mode of action (MOA): physical barrier (like keratins) and broad microbicidal activity (like cathelicidins), as well as safety features for use in abundance. Here, we propose Amicidin-alpha PFC (prolonged field care) – a dry-fabricated, lightweight powdered form of Amicidin-alpha – designed to specifically meet the needs of prolonged field care. This project will provide first-in-patient data on subjects with limb trauma involving open fracture.