Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene

Launched by UNIVERSITY OF ROMA LA SAPIENZA · Dec 4, 2024

Keywords

ClinConnect Summary

This is a small, early-stage study in Italy to test whether hydrogen sulfide–rich spa water can help wounds that are hard to heal, especially when they are infected or have a lot of bacterial activity. About 30 adults will be randomly assigned to one of two ways to receive 20 minutes of the water: (A) damp gauze packs placed on the wound, or (B) full limb immersion in the spa water. Treatments are given every 48 hours until the wound heals. The people assessing the results will not know which treatment a participant received to keep the comparison fair.

If you’re eligible (adults 18 and older with an acute or chronic wound needing care; infections or biofilms allowed; other health conditions may be present), you’ll have a baseline wound swab and several measurements taken before treatment and after each session for up to about a year. These include a standard wound healing score, wound size, skin moisture loss, wound pH, and imaging that looks at bacteria on the wound, plus a microbiome check. There’s a follow-up about 3 months after healing to assess scar quality and any relapse. The study aims to see if the sulfurous water changes the wound’s bacteria, improves the wound environment, speeds healing, and whether the gauze-pack method or full immersion works better. Safety is watched closely throughout the trial, which is run at Terme di Roma Acque Albule in Bagni di Tivoli, near Rome.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients \>18 years old
• • Any comorbidities (except very severe I, II immune deficiencies)
• • Any systemic drug therapy
• • Any associated dressing (except peroxides)
• • Acute or chronic wounds requiring wound care treatment
• • Genital/oral wounds
• • Infected wounds, including MDR pathogens
• • Biofilmed wounds
• Exclusion Criteria:
• • Unexplored fistula
• • Enteric fistula
• • Exposure of fascia, vessels, bones, organs
• • Pyoderma Gangrenosum (monotherapy)
• • Implanted or penetrating devices (CVC , Port-a-cath, drainages, peritoneal dialysis, external fixators....etc.)
• • Exposed implants(nails, plates, internal defibrillator, Pace maker)
• • Local antibiotic therapy (not supported by antibiogram)