Seroma is the most common adverse effect of many surgical procedures and is estimated to occur in up to half of all abdominoplasties. Because abdominoplasty is one of the most commonly performed aesthetic procedures in the United States (150,000/year) seroma formation is a major concern. Problems related to seroma accumulation include patient discomfort, incisional disruption and surgical site infection. These problems lead to additional undesirable procedures, diminish cosmetic outcomes and significantly escalate healthcare costs. Various strategies have been utilized to mitigate postoperative seroma occurrence including surgical approach, talc instillation, closed suction drains, immobilization, fibrin/thrombin sprays, compression, and sclerosants. All of the approaches seek to obliterate the dead space by facilitating the re-adherence of disrupted tissue planes. Currently available commercial adhesives include fibrin glues and biopolymers, such as BioGlue®/Tisseel® and TissuGlu®, respectively. These products are limited by their poor performance in aqueous environments, weak adhesion on wet tissues, short degradation time, dangerously high swelling ratios, and/or cytotoxicity due to toxic chemical crosslinking for adhesion. Clinical outcomes are often unsatisfactory and post-operative seroma formation is common even when the current adhesives are used as an adjunct to drains. The Objective of this STTR Phase I proposal is to develop Aleo BMEs proprietary super-strong and elastic biphasic glue (BP Glue) for the prevention of post-operative seroma following abdominoplasty. The novelty of BP Glue lies in the adoption of a unique adhesion mechanism that combines a plant-inspired bioadhesion strategy and particle packing theory borrowed from the cement industry for the development of an aqueous biomimetic wet tissue adhesive for seroma control in abdominoplasty. The scientific premise of the proposal is as follows; 1) BP Glue is the first aqueous super-strong elastic tissue adhesive to achieve equivalent shear strengths (80 KPa) to Dermabond® (cyanoacrylate) and TissuGlu® through physical bonding. No toxic chemical crosslinking is involved in BP Glue adhesion; 2) BP Glue is effective to prevent seroma formation in a preclinical animal model, and 3) BP Glue adhesion mechanism simulates that of English-Ivy under which nanoparticles secreted by English-Ivy are ionically crosslinked to form an inter-locking capable of binding to rough surfaces, such as buildings, trees or biological tissues in combination with that of particle packing theory under which compositing particles with optimal size difference maximizes the cohesive strength of the resultant composite materials. The expected outcome of this proposal is that we will develop a new fully synthetic, bioinspired, elastic, and super- strong biodegradable aqueous adhesive sealant, BP Glue with superior physiochemical properties over the existing adhesives to address the challenging clinical problems in the management of seroma prevention post- abdominoplasty.
Public Health Relevance Statement: Project Narrative Seroma is the most common adverse effect of many surgical procedures and is estimated to occur in up to half of all abdominoplasties. The Objective of this STTR Phase I proposal is to develop Aleo BMEs proprietary super- strong and elastic biphasic glue (BP Glue) for the prevention of post-operative seroma following abdominoplasty.
Project Terms: Abdomen; Address; Adherence; Adhesions; Adhesives; Adoption; Adverse effects; Animal Model; aqueous; Binding; Biological; Biomimetics; Biopolymers; Cells; Clinical; cohesion; Complication; Cosmetics; crosslink; Cyanoacrylates; cytotoxicity; Dangerousness; Dermabond; Development; Domestic Pig; Elastic Tissue; Environment; Esthetics; Evaluation; Fibrin; Fibrin Tissue Adhesive; Formulation; Glues; Health Care Costs; Hedera helix; Immobilization; In Vitro; in vivo; Incidence; Industry; Inflammation; Lead; Life; microbial; Modeling; nanoparticle; Nature; Operative Surgical Procedures; Outcome; particle; Patients; Penetration; Performance; Pharmacopoeias; Phase; Plants; Poison; Polyurethanes; Postoperative Period; pre-clinical; prevent; Prevention; Procedures; Property; Protocols documentation; Reporting; Sclerosing Agents; Seroma; Shear Strength; Small Business Technology Transfer Research; Suction; Surface; Surgical incisions; Surgical Wound Infection; Swelling; Talc; theories; Thrombin; Time; Tissue Adhesives; Tissues; Trees; United States; waterborne
