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Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 10, 2024 (before its estimated December 30, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT06725797
Lead Sponsor University of Roma La Sapienza
Collaborators: Università degli studi di Roma Foro Italico
Conditions
(from sponsor)
Ulcers, Wound - in Medical Care, Wounds and Injuries, Wound Healing, Wound Care, Venous Ulcers, Wound Cleansing
Related terms Ulcer, Varicose Ulcer, Wounds and Injuries
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov