Clinical Research Directory

Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene

This is an interventional double arms pilot study on the effectiveness of hydrogen sulfide (H2S) rich and microbiologically pure spa sulphurous water, in the wound hygiene of hard-to heal wounds, set in an italian spa facility. At least 24 subjects enrolled according to selection criteria will be 1:1 randomized in two intervention groups: the former (A) undergoing pack of sulphurous water on soaked gauzes for 20 minutes, the latter (B) undergoing full limb immersion for 20 minutes. Differences among the two arms will be assessed as changes in wound microbiome, wound pH, Trans epidermal water loss (TEWL), 1000x ex-vivo microscope imaging, wound fluorescence imaging for bacterial colonization and longitudinal shifts in wound sizing and peculiar features according to the Bates-Jensen Wound Assessment Tool (BWAT). Time required for re-epithelization will be recorded together with any adverse reactions or events for both arms and compared. The study aims at assessing the effectiveness of hydrogen sulfide exogenous supply on infected or colonized hard to heal wounds and which way of administration (pack Vs immersion) could have prevailing effects.