OTA Directed Topic Research Grant

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OTA is accepting directed topic grant proposal sponsored by LifeNet Health for the following hypothesis:

“DermACELL AWM Acellular Dermal Matrix provides an efficacious alternative to full-thickness or split-thickness skin grafting for coverage of fracture-related open wounds”  

(Scroll down to apply)

The purpose of this RFP is to fund a study examining Dermacell AWM as a coverage alternative to autogenous skin grafting for open, extremity related fracture wounds. Often, patients requiring these types of grafts are cared for by a team of surgeons, including but not limited to orthopaedic surgeons, plastic surgeons, and podiatrists. Grant proposals taking a collaborative approach are welcome.

Dermacell is a human acellular dermal matrix (hADM), which is decellularized using Matracell®, a proprietary and patented technology that removes ≥ 97% of donor DNA without compromising the desired biomechanical or biochemical properties of the graft.

Guidelines will be provided by LifeNet Health to assure proper application technique. Familiarity with Dermacell AWM’s appearance throughout the course of healing can prevent unnecessary removal.  LifeNet Health Clinical Wound Specialist will be available to work with physicians not familiar with application of the product (Note: Dermacell AWM will be provided by LifeNet Health but will not participate in the design, conduct or interpretation of study results).

Successful proposals will outline a program that achieves the following:

  1. Patient recruitment will be completed within a 12-month period from the time of funding.   No-cost extensions will be granted.  Successful research proposals must outline a clear plan that demonstrates infrastructure is in place to achieve patient recruitment in the designated time period.
  2. Inclusion criteria:
    • Trauma-related complex wounds and/or open fracture requiring soft tissue, tendon, or bone coverage typically accomplished by full-thickness or split-thickness skin grafting
  3. Exclusion criteria:
    • Inadequate perfusion to the graft site (trauma-related or preexisting)
    • Systemic infection or local infection in fractured limb
    • Have a malignancy or have undergone chemotherapy/radiation therapy within the past 30 days
    • Have elevated ( > 3x upper limit of normal) liver or kidney function tests
    • Receiving immunosuppressant medications
    • Are enrolled in any other interventional clinical trial
  4. The following are suggested for primary outcomes:
    • Time to granulation, defined as complete coverage of the exposed soft tissue and/or bone with collagen-rich connective tissue
    • Time to re-epithelialization
  5. Secondary clinical measures:
    • Number of applications of DermACELL
    • Need for flap (i.e. failure to avert larger plastic surgery)
    • Infection rate
    • Fracture union
    • Any adverse event (AE) that leads to ICU admission or operation
  6. Complications will be accurately documented.

Eligibility: Either the principal investigator or co-principle investigator must be a member of the Orthopaedic Trauma Association

Funding: Total funding is $50,000 (Two payments of $25,000 over 18-moths cycle) and will include direct and indirect costs.  No salary support will be allowed for participating surgeons..

To review the complete research grant application guidelines click here.

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