The broader impact/commercial potential of this I-Corps project is the development of a point-of-care product that diagnoses and treats bacterial infection in chronic wounds based on theranostic nanofiber technology. The goal is to improve clinical workflow, promote wound healing, and stop sepsis before it starts. Sepsis, an extreme response to an infection is potentially life-threatening. It increases length of hospital stays, often requires treatment in intensive care units, and significantly increases hospital and pharmacological costs. One-third of sepsis cases and nearly half of all sepsis-related deaths in 2017 were due to wound infection. Reliance on clinical signs and symptoms to detect infection in chronic wounds has proven unreliable. Use of swab cultures is no more accurate. Tissue biopsies provide more accurate results, but are costly and indications take longer to acquire. Inaccurate diagnosis or patient non-compliance in care of a wound may result in antibiotic overuse or sepsis. The proposed solution detects rising bacterial colonization, provides visual indication of bacterial colonization above a threshold, and releases medication in response, preventing infection and stopping sepsis. These features may provide significant improvements in provider workflow and patient outcomes, both major cost drivers in clinical and low-resource settings.
This I-Corps project is based on the development of a novel theranostic (diagnostic and therapeutic) nanofiber membrane focused on prevention of infection in chronic wounds caused by severe burns, and by pressure, venous, and diabetic ulcers. Wound dressings often are extremely painful to remove, particularly for severe burn wounds. Requirements for pain management may significantly impact clinical workflow and influence patient compliance outside the clinic. There is high risk for infection and the onset of sepsis. Experimental results confirm that detection of bacterial colonization, visual notification, and responsive release of antibacterial agents may be achieved using the proposed nanofiber membrane. Incorporating colorimetric dyes provides tunable sensitivity for the detection of infection. Using an antibacterial agent in bioresponsive nanofiber enables on-demand release of a biocide. On demand release enables extended-time wound coverage to support healing and reduce pain by remaining in continuous contact with a wound bed during and between wound dressing changes. A novel process is under development for fabricating well-structured, cross-aligned nanofiber membranes needed to optimize membrane surface exposure to a wound bed and increase detection sensitivity. The sensitivity and responsiveness of multi-layer membranes comprising cross-aligned, bioresponsive nanofibers using antibacterial nanofiber compositions will be evaluated.
This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.