The long-term goal of this project is to create a sprayable surgical adhesive which would satisfy the surgical need for a strong, easy-to-use adhesive to adhere planar flaps of tissue. This novel adhesive will reduce fluid accumulation after surgery by eliminating dead space in the wound and maintaining tissues in position for natural healing to occur. Seroma formation is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. Traditional wound closure approaches such as sutures provide point-to-point fixation, which is inadequate to fully adhere planar surfaces. Surgeons need sprayable glue that can fully adhere planar flaps of tissue without requiring direct contact with the tissue. During the Company's Phase I SBIR project, Cohera successfully demonstrated the feasibility of developing a resorbable, sprayable adhesive, TissuGlu"""""""", as well as a functional prototype of the spray delivery device. Cohera proposes to test the hypothesis that its novel product will meet the FDA requirements for safety and efficacy, by demonstrating that it is biocompatible and effective at reducing fluid accumulation after surgery in both animal models and human clinical trials. During the proposed Phase II SBIR project, we will achieve the following Specific Aims: 1) Finalize delivery device development. Primary goals include a) preparing custom molding designs for device components, b) establishing filling procedures for adhesive and mobilizing agent, c) manufacturing and assembling an initial run of 100 prototype devices, and d) initiating shelf life and stability testing of product in delivery device. 2) Complete pre-clinical testing for Investigational Device Exemption (IDE) submission to the FDA. Primary goals include a) completing specific physical and chemical characterization studies on adhesive product, b) completing biocompatibility and genotoxicity testing on adhesive product, and c) completing efficacy studies in an acceptable animal model. 3) Establish GMP manufacturing, packaging, and sterilization of adhesive. Primary goals include a) generating manufacturing protocols and batch release criteria, b) establishing sterilization protocols and packaging and labeling requirements, and c) completing pilot scale production batch for first human clinical trials. 4) Perform initial clinical study (feasibility phase) in human patients to support Pre-market Approval (PMA) submission. Primary goals include a) completing proposed clinical trial design for review by FDA, b) submitting a completed IDE application to the FDA, c) completing the feasibility clinical trial in a small set of patients.
Seroma formation is among the most common post-surgical complications, occurring in up to 50% of certain surgical procedures. The long term goal of this project is to create a sprayable surgical adhesive that will reduce fluid accumulation after surgery by maintaining tissues in position for natural healing to occur. The use of the adhesive to prevent seroma formation will reduce patient discomfort, decrease risk of infection, and speed patient recovery. ? ? ?
| Hunstad, Joseph P; Michaels, Joseph; Burns, A Jay et al. (2015) A Prospective, Randomized, Multicenter Trial Assessing a Novel Lysine-Derived Urethane Adhesive in a Large Flap Surgical Procedure without Drains. Aesthetic Plast Surg 39:616-24 |
