SBIR Phase I: Development of a barrier film to prevent post-operative internal scarring

Sintact Medical Systems, Llc, Bloomington IN

Investigators

Abstract

Phase I project is to improve the quality of care for patients who suffer from internal scarring triggered by abdominal surgery. Patients with severe scar formation often require a follow-up surgical procedure called adhesiolysis. Adhesiolysis is performed to cut away the internal scars that have bridged different organs or caused intestinal obstructions. Annually, 540,000 adhesiolysis procedures are performed in the US. These secondary surgical procedures can also cause additional scar formation resulting in cycles of repeat procedures. While current barrier products reduce the severity of internal scarring by 51%, they all degrade after a few weeks. Furthermore, none are approved for use during laparoscopic procedures, a preferred technique for adhesiolysis. Traditionally, products used for scar reduction have been made from materials that degrade. In contrast, the proposed device is made from a nondegrading material that has been safely used in the body for the past 40 years. This stronger material enables laparoscopic use and ensures separation of internal organs. As such, this proposed device has shown promising results in pilot studies and could lead to a new standard of care for patients at risk for severe internal scar formation. The proposed project aims to develop an implantable barrier film to reduce scar formation inside the body after abdominal surgery. Current conventional thinking in biomaterial selection for scar reducing barrier films has relied primarily on resorbable materials. However, these barriers do not perform well enough to be utilized in severe adhesion cases nor laparoscopic procedures. The implementation of a permanent barrier in this space stems from the development of non-resorbable synthetic meshes for the repair of abdominal and pelvic hernias. Furthermore, the non-degrading property of the permanent film ensures long-term control over the surface topography, which has been shown to play a substantial role in cell adhesion. The project goals are to evaluate a non-resorbable barrier that maintains an extremely smooth, mildly hydrophobic surface in the healing process of internal tissue surfaces. A twelve week definitive animal (rabbit) study utilizing an established surgical adhesion abdominal model will determine the efficacy of the proposed device to reduce surgical adhesion formation as compared to a control group and a commercially available product. If successful, the results will influence decisions concerning material composition for future anti-adhesion, anti-scarring, and other implants in addition to providing a better understanding of internal wound healing pathways