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1.1.2 Main technological and scientific objectives

(A) Optimization of color reaction between enzyme substrates and the wound infection enzymes (myeloperoxidase, lysozyme and elastase)

A1 Myeloperoxidase (MPO) substrates - phenolic molecules developing color upon oxidation with MPO (non-interacting with heme)

A2 Lysozyme(LYS) substrates - optimization of color reaction with dye-labeled Micrococcus luteus (M. luteus) peptidoglycan fragments or specific oligosaccharides 

A3 Elastase (HNE) substrates - synthesis of chromogenic peptides/gelatin with specific cleavage sequences

A4 Internal standard - Integration of an internal standard using the displacement concept e.g. to measure protein content in wound fluid

A5 Development of color trapping strategies to generate a signal readable via an external window in the dressing

(B) Lab prototype: production and characterization of the ‘in situ infection diagnostic material’

B1 Continuous process for production of the ‘in situ wound infection diagnostic material’ by immobilization of the detector and capturing reagents using ink-jet printing

B2 Semi-continuous process for production of the in situ wound infection diagnostic material’ by immobilization of the detector and capturing reagents based on:

  • Impregnation: spraying/dispensing of the enzyme-substrates and capturing compounds using contact and non-contact tips
  • Chemical immobilization
  • Ultrasound assisted immobilization – simultaneous sonochemical production of enzyme substrate nanoparticles, and their embedding on the diagnostic material

B3 Assessment of the efficiency for developed immobilization protocols

B4Assembling of a lab prototype and characterization

 (C) In vitro/in vivo assessment of the ‘in situ wound infection diagnostic material’

C1 In vitroefficacy

C2 In vitrobiocompatibility - the diagnostic material will be assessed for biocompatibility based on the response of fibroblasts, immune cells and epidermal cells

C3 In vivobiocompatibility, leaching and efficacy - individual components will be assessed for stand-alone toxicity as required by the regulators after consultation and demonstration of the prototype

(D) In human clinical studies: ex vivo/in vivo

D1 Ex-vivo study 1 - assessing color reactions by contact of wound fluids and enzyme substrates

D2 Ex-vivo study2 -assessing color reactions of wound fluids and the ‘in situ wound infection diagnostic material’

D3In-vivo study -treating patients based on the information derived from the ‘in situ wound infection diagnostic material’to select therapy in real time with assessment by comparison of clinical outcomes and relative treatment cost

(E) Up-scaling, LCA and LCC studies and process engineering for mass production

E1 Up-scale the dye-labeled enzyme-substrates for production of 100 infection detectors per day

E2 Upscaletheprocess for materials functionalization (reagents immobilization) 

E3 Packaging, stability, and storage studies

E3 Life cycle assessment (LCA) and life cycle cost assessments (LCC) of the prototype production - these studies will support the studied processes while supplying recommendations to reduce cost and environmental impact for the up-scaling process

E4 Process engineering for mass production, e.g. 5000 infection detectors per day

(F) Towards CE marking, market survey, and business plan

F1Requirements for CE Mark

F2 Market estimates, reimbursement prospects and revenue projection by market

F3 Business plan based on the SMEs and industry capabilities in the consortium, and pilot outputs  

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