Papers by Author: Nick Coleman

Abstract: Thick Section 3D Bioresorbable Scaffolds Are Proposed as a Potential Alternative to Biologic Skin Grafts and Supportive Fillers for Non-Healing Chronic Wound Ulcers. Synthetic Bioresorbable Scaffolds Avoid Human and Animal Derived Contamination Risks, Provide Feasible Shelf Life, Availability and Cost, and Act as a Consistent Platform for Localized Drug Elution. A Bioresorbable Polyester-Based Scaffold (Infilon™) Was Investigated as a Drug Delivery Vehicle for Chloramphenicol Antibiotic (CAP) Combined with a Bioactive Envelope. the Effect of Varying Envelope Protocols on Antibiotic Elution Profile and Antimicrobial Potency on Scaffolds Were Analysed. the Maximum Antibiotic Loading Efficiency of the Scaffold Was 10.18% W/w. the Antibiotic Elution Profile Showed that the Burst Phase Lasted One Hour Subsequent to a Sustained Phase Approaching near Asymptotic Release. Envelope Permutations of Bulk Metallic Glass (BMG) and Bioglass 45S5 Reduced the Total Amount of Antibiotic Released by 1 to 1.8 Mg while the Polyethylene Oxide Envelope Extended the Burst Phase to 2 Hours. CAP Loaded Scaffolds Demonstrated Antimicrobial Effectiveness for 24 Hours. Results Show Potential for the Infilon™ Scaffold to Be Used as a Platform for Localized Antibiotic Delivery. Delivery Profiles Can Be Enhanced with Additional BMG or Bioglass Envelopes. this Approach Has Opportunity to Provide a Synergistic Coupling of Antimicrobial Action and the Harbouring of Granular Tissue Subsequent to Final Wound Healing.

Abstract: The manufacturing process for in vitro tissue culture products and medical devices relies on a validated sterilization route for ensuring product sterility, safety and performance. Two key aspects that contribute toward final sterilization validation are (1) the reliable estimation of product bioburden and (2) the development of a proficient sterile packaging system. Bioabsorbable composite systems and architecture of tissue scaffolds can lead to numerous challenges for bioburden testing and packaging design. This study is concerned with the development of bioburden assessment methods and packaging systems for Variotis™; a soft tissue engineering scaffold. A bioburden test method relying on mechanical agitation was established. Bioburden assessment was achieved by recovering Geobacillus stearothermophilus spore inoculant for analysis. A packaging system was developed which provides adequate protection for Variotis™ scaffolds while meeting other user/sterilization requirements for research grade product. The guidelines and design approaches included in this study are generally applicable to other tissue engineering scaffold and medical devices.