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

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Phase I project is to improve the quality of care for patients who suffer from internalscarring triggered by abdominal surgery. Patients with severe scar formation often require afollow-up surgical procedure called adhesiolysis. Adhesiolysis is performed to cut away theinternal scars that have bridged different organs or caused intestinal obstructions. Annually,540,000 adhesiolysis procedures are performed in the US. These secondary surgicalprocedures 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 degradeafter a few weeks. Furthermore, none are approved for use during laparoscopic procedures, apreferred technique for adhesiolysis. Traditionally, products used for scar reduction have beenmade from materials that degrade. In contrast, the proposed device is made from a nondegradingmaterial that has been safely used in the body for the past 40 years. This strongermaterial enables laparoscopic use and ensures separation of internal organs. As such, thisproposed device has shown promising results in pilot studies and could lead to a new standardof care for patients at risk for severe internal scar formation.The proposed project aims to develop an implantable barrier film to reduce scarformation inside the body after abdominal surgery. Current conventional thinking in biomaterialselection 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 norlaparoscopic procedures. The implementation of a permanent barrier in this space stems fromthe development of non-resorbable synthetic meshes for the repair of abdominal and pelvichernias. Furthermore, the non-degrading property of the permanent film ensures long-termcontrol over the surface topography, which has been shown to play a substantial role in celladhesion. The project goals are to evaluate a non-resorbable barrier that maintains anextremely smooth, mildly hydrophobic surface in the healing process of internal tissue surfaces.A twelve week definitive animal (rabbit) study utilizing an established surgical adhesionabdominal model will determine the efficacy of the proposed device to reduce surgical adhesionformation 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 internalwound healing pathways