Adhesion formation after intra-abdominal surgery poses a huge health risk, cited as a leading cause of small bowel obstruction and female infertility. Methods to prevent these adhesions are currently limited to barrier films which are difficult to place and are often restricted to use preventing adhesions to the surgical incision sie, leaving the bulk of the abdominal contents unprotected. This program is for the development of a low-cost, sprayable barrier that will flow around and adhere to the internal tissues of the abdominal cavity, providing broader protection from adhesions throughout the abdominal cavity. Because of the nature of the components in this product, the proposed material will be biocompatible and biodegradable as it provides more complete protection than is available from currently marketed products. This program will focus on the development and characterization of the material components and delivery system to create the barrier formulations. These resultant formulations will then undergo a series of in vitro characterization tests to assess thei ability to effectively serve as a barrier to adhesion formation and small animal in vivo demonstration of efficacy. Finally, the most promising formulations will undergo assessment in a definitive preclinical animal model in rabbits. The results will be the basis for product commercialization efforts and submission to the FDA.
The material to be developed will provide a low-cost, more effective alternative to current approaches for the prevention of postoperative adhesions. The novel agent is being developed to address the problem of adhesion formation within the abdominal cavity between tissues that are difficult to protect with a simple barrier film. The material being developed in the program has many desirable properties, being low-cost and sprayable, with the potential to be adapted for future use in a number of other biomedical applications including laparoscopic procedures, drug delivery systems, and wound healing purposes.
