The main goal of SPIR is the development of advanced smart dressings for wound care treatment.

The project will integrate results from two Spokes:

• Spoke 1 – WP4: new BioGlasses (BG) compositions enriched with strontium and magnesium and with low alkali oxide content were incorporated into collagen-based hydrogel patches. Bioprinting technology was used to create patches with controlled porosity and geometry (TRL6). Tests on damaged skin biopsies (SDS-induced chronic wound model) showed restoration of the epidermal barrier, with histological features comparable to normal skin.

• Spoke 3 – WP1: new inks based on natural materials were developed for 3D printing biosensors on substrates like fibroin, sericin, and kombucha. These devices, based on organic electrochemical transistors and impedimetric electrodes, were integrated into flexible wearable patches (TRL6). They can detect early inflammatory markers using real physiological fluids (plasma, saliva).

SPIR project innovation:
Integration of the regenerative BG-hydrogel patch from Spoke 1 with the sensing systems from Spoke 3, enhanced via bioprinting technology. The resulting smart patch will allow:

• constant monitoring of the inflammatory state during application

• early detection of infections

• medical intervention at the onset of inflammatory or infectious events

The regenerative potential and functional sensing of SPIR prototypes will be tested in vitro and in ex-vivo skin models using human skin in a space environment (TRL7).

Work Packages

• WP1 – Coordination (UNIMORE, Prof. Luigi Rovati)
  Overall project management and supervision.

• WP2 – Sensing (CNR-IMEM & IEOS-CNR)

  • Development of electronic pH sensors on commercial dressings.

  • Development of novel sensing elements for specific cytokines as inflammation markers.

  • Multiplex analysis by IEOS-CNR to identify relevant molecules in normal vs. damaged skin.

• WP3 – Patch Fabrication (UNIMORE)

  • Manufacturing of BG by UNIMORE.

  • Integration of BG with hydrogel and sensor elements.

  • Chemical characterization of prototypes by TPM.

• WP4 – 2D Biological Validation (UNIMORE)

  • Biological tests on 2D wound healing models.

  • Evaluation of regenerative potential by histology (restoration of skin architecture).

• WP5 – Ex-vivo Model (IEOS-CNR)

  • Organ culture experiments using damaged human skin biopsies treated with chemicals and lipopolysaccharide (LPS) to mimic chronic wounds and bacterial infection.

  • Assessment of cytokine secretion (more than 50 markers) via Multiplex to evaluate inflammation and regeneration.

Impact and Regulatory Alignment

• SPIR will represent a novel smart patch combining regenerative and sensing functions.

• It will reduce inflammation (thanks to BG properties) and regenerate damaged skin.

• The sensing element will enable real-time monitoring of wound status.

• Chemical and biological characterization will address MDR 745/2017 requirements.

Final outcome: a prototype close to industrialization, offering clinics and patients an advanced product for chronic wound treatment, merging regenerative medicine with wearable biosensing.