Research Project
7266829
[unreadable] DESCRIPTION (provided by applicant): 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. What surgeons require is a sprayable "glue" that can fully adhere planar flaps of tissue without requiring direct contact with the tissue. The hypothesis of the proposed Phase I research project is that Cohera's proprietary biocompatible polyurethane tissue adhesive can be engineered into a sprayable formulation that will be effective in closure of planar tissues based on its physical properties, delivery process and adhesive strength. Accommodating the physical constraints required to deliver a viscous fluid by spray in the operating room environment will require significant innovation in both product formulation and device design. To test this hypothesis, the following specific aims will be accomplished: 1) Optimize the physical characteristics of the tissue adhesive for spray delivery. In brief, the physical characteristics of the adhesive (such as viscosity, Young's modulus, cure time and tensile strength) must be engineered to produce an adhesive that can be delivered in small volumes by spray in an operating room environment while meeting established performance requirements. 2) Develop delivery device prototypes to spray adhesive evenly onto planar surfaces. A spray tip will be developed which can predictably and reliably disperse a viscous fluid when attached to a syringe delivery device. 3) Establish that adequate bonding strength can be achieved using spray delivery system. The novel formulation will be tested with the novel delivery device to establish that the product performs adequately when delivered by the new device. During Phase II of the project, the sprayable adhesive will be tested in vivo to demonstrate efficacy in closure of planar tissues and preventing post-surgical fluid accumulation. This research project will include finalizing the product specifications including both product formulation and delivery device, performing efficacy testing in an accepted animal model for seroma prevention, and performing feasibility studies in humans to provide data to the FDA in support of a Pre-market Approval (PMA). . 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 which would satisfy the surgical need for a strong, easy-to-use adhesive to coapt 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. [unreadable] [unreadable] [unreadable]
