Safety trial assessing 1.77 cm² H₂O₂ producing electrochemical bandages on healthy human skin

Mammalian skin maintains complex repair mechanisms after barrier disruption. Chronic wounds develop when these events are not efficiently completed, increasing infection risk. With ~2% of the population afflicted yearly, chronic wound care needs new technologies. Here, a Phase 0/1 study of one such therapeutic intervention is presented- H₂O₂ (hydrogen peroxide)-producing electrochemical bandages (e-bandages) controlled by wearable micropotentiostats. The e-bandages generate H₂O₂ in precise, micromolar concentrations for controlled time intervals. Safety of sterile, 1.77 cm² H₂O₂-generating e-bandages loaded with 3M hydrogel containing 0.9% sodium chloride was evaluated on healthy adult forearms. Twenty participants were assigned to one of five groups, with groups defined by polarization durations. e-Bandages were worn for 24 h and adverse effects evaluated. Most participants experienced no device-related ramifications. Some described discomfort from Tegaderm™, used to secure the devices, and/or hydrogel discoloration. In conclusion, 1.77 cm² H₂O₂-generating e-bandages were well tolerated on healthy human skin for up to 24 h, though further development is needed, supporting future investigation of this therapeutic for chronic wound management. This trial was registered with ClinicalTrials.gov under the identifying number NCT05940207 on 11/07/2023 (first posted date).