Phase II year
2009
(last award dollars: 2010)
Phase II Amount
$1,783,138
A hernia occurs when part of an internal organ bulges through a weak area of fascia, with most hernias occurring in the abdomen. Surgical hernia repair is one of the most commonly performed surgeries in the US. While using prosthetic mesh as a reinforcement has significantly improved surgical outcomes, the rate of hernia recurrence can be more than 50%. Current synthetic meshes are associated with numerous complications, including increased risk of infection, prosthetic shrinkage, and host-foreign body reactions, leading to a diminished postoperative patient quality of life. The recent introduction of various biologic meshes derived from modified human or animal tissues has demonstrated lower rates of infection as compared to their synthetic counterparts. Equally important, effective immobilization of the mesh against the abdominal wall is critical to hernia repair success. Currently, sutures, staples, or tacks are used to fixate synthetic and biologic meshes in place, but these methods can be a source of nerve damage and chronic discomfort. Thus, there continues to be a need to develop alternative fixation methods that can effectively secure the mesh to the abdominal wall as well as improve long-term biocompatibility of these meshes. Marine mussels provided the inspiration for the new technology presented in this proposal. By releasing rapidly hardening, tightly binding adhesive proteins, marine mussels have the ability to anchor themselves to various surfaces in a wet, turbulent, and saline environment. Both natural proteins and their synthetic mimics can bind strongly to various substrates ranging from biological tissues to metal surfaces. In this proposal, biomimetic synthetic adhesives will be combined with a natural scaffold to create a novel bioadhesive prosthetic. The intent of such a construct is to create an effective repair with minimized long-term infection rate and chronic patient discomfort typically associated with permanent prosthetic materials and current fixation methods. The feasibility of using such a material for hernia repair will be tested.
Public Health Relevance: Bioadhesive Membrane Construct for Hernia Repair Hernia repair is one of the most frequently performed surgical procedures in the United States. Current repair methods and materials have exhibited mixed success, but each has limitations such as high recurrence rate and persistent patient discomfort. The development and evaluation of a novel bioadhesive membrane construct for hernia repair is described here.
Thesaurus Terms: 1,2-Benzenediol; 1,2-Dihydroxybenzene; 2-Hydroxyphenol; 3,4-Dihydroxyphenylalanine; 3-Hydroxy-Dl-Tyrosine; Abdomen; Abdominal; Abdominal Wall; Abdominal Wall Structure; Adhesions; Adhesives; Adverse Reactions; Affect; Amino Acids; Anatomic; Anatomical Sciences; Anatomy; Animal Model; Animal Models And Related Studies; Animals; Area; Aspiration, Respiratory; Binding; Binding (Molecular Function); Biocompatible; Biological; Biomechanics; Biomimetics; Body Tissues; Breathing; Catechols; Cell Culture Techniques; Cells; Characteristics; Chronic; Clinical Trials; Clinical Trials, Phase I; Clinical Trials, Phase Ii; Clinical Trials, Unspecified; Collagen; Data; Defect; Deposit; Deposition; Development; Devices; Dihydroxyphenylalanine; Dopa; Drug Formulations; Drugs; Early-Stage Clinical Trials; Environment; Evaluation; Exhibits; Family Suidae; Fascia; Fibroblasts; Film; Fixation; Food; Foreign-Body Reaction; Formulation; Formulations, Drug; Funding; Future; Guidelines; Hernia; Hernia, Ventral; Human; Human, General; Hydrogen Oxide; Immobilization; In Vitro; Infection; Inflammatory Response; Inhalation; Inhaling; Inspiration, Respiratory; Logic; Lytotoxicity; Macrogols; Mammals, Rabbits; Man (Taxonomy); Man, Modern; Marines; Medical Device; Medication; Membrane; Metals; Methods; Methods And Techniques; Methods, Other; Mimetics, Biological; Miniature Swine; Minipigs; Modeling; Molecular Interaction; Muscle; Muscle Tissue; Mussels; Nerve; Nervous; Operation; Operative Procedures; Operative Surgical Procedures; Organ; Oryctolagus Cuniculus; Outcome; Oxidants; Oxidizing Agents; Peg; Patients; Pattern; Performance; Persons; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Phase 1 Clinical Trials; Phase 2 Clinical Trials; Phase I Clinical Trials; Phase I Study; Phase Ii Clinical Trials; Pigs; Polyethylene Glycols; Polyethylene Oxide; Polyethyleneoxide; Polymers; Polyoxyethylenes; Post-Operative; Postoperative; Postoperative Period; Preparation; Procedures; Production; Property; Property, Loinc Axis 2; Prosthesis; Prosthetic Device; Prosthetics; Proteins; Psychological Reinforcement; Publishing; Pyrocatechols; Qol; Quality Of Life; Quinone Compound; Quinones; Rabbit, Domestic; Rabbits; Reaction; Recurrence; Recurrent; Reinforcement; Reinforcement (Psychology); Research; Resistance; Risk; Saline; Saline Solution; Science Of Anatomy; Secure; Series; Shear Strength; Source; Sterilization; Sterilization For Infection Control; Suidae; Surface; Surgical; Surgical Interventions; Surgical Mesh; Surgical Procedure; Surgical Sutures; Sutures; Swine; Swine, Miniature; Techniques; Testing; Textiles; Tissue Engineering; Tissues; United States; Ventral Hernia; Water; Work; Abdominal Wall; Adhesive Polymer; Aminoacid; Anatomy; Animal Tissue; Base; Beta-Hydroxytyrosine; Biocompatibility; Biomaterial Compatibility; Clinical Investigation; Clinical Practice; Clinical Relevance; Clinically Relevant; Copolymer; Covalent Bond; Cytotoxicity; Cytotoxicity Test; Drug/Agent; Electron Acceptor; Engineered Tissue; Experiment; Experimental Research; Experimental Study; Fabric; Functional Group; Gene Product; Good Laboratory Practice; Immobilization Of Body Part; Implant Material; Implantation; Improved; In Vivo; Inspiration; Interest; Membrane Structure; Migration; Mini Pig; Model Organism; New Technology; Next Generation; Novel; O-Dihydroxybenzenes; Ortho-Dihydroxybenzenes; Orthopedic Freezing; Performance Tests; Phase 1 Study; Phase 1 Trial; Phase 2 Study; Phase 2 Trial; Phase I Trial; Phase Ii Trial; Polycaprolactone; Porcine; Product Development; Protocol, Phase I; Protocol, Phase Ii; Public Health Relevance; Repair; Repaired; Research Study; Resistant; Sample Fixation; Scaffold; Scaffolding; Study, Phase Ii; Success; Suid; Surgery