Clinical trial NCT06725797: Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene
Official title: Pilot Study on the Effectiveness of Sulphurous Thermal Water in Wound Hygiene: Spa Wound Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ulcers
Wound - in Medical Care
Wounds and Injuries
Wound Healing
Wound Care
Venous Ulcers
Wound Cleansing
Keywords: wound hygiene
chronic wound
sulfurous water
spa thermal water
wound care
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Università degli studi di Roma Foro Italico
First posted: 2024-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is an interventional pilot trial assessing the efficacy of hypothermal sulphurous thermal water (STW) in the wound hygiene of patients affected by hard to heal, chronic, infected wounds. The eligible subjects will be 1:1 randomized in two arms and treated with pure sulfurous spa water, already authorized for medical drinking therapy, on soaked gauzes (GROUP A) or for full limb immersion (GROUP B) for 20 minutes. Ph, Trans epidermal water loss (TEWL), healing rate (Bates-Jensen Wound Assessment Tool) wound fluorescence imaging for bacterial colonization and wound microbiome will be tested at 3 timepoints: T0 (prior treatment), T1 (just after treatment) , Tf (complete wound re-epithelization).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The effectiveness of sulphurous thermal waters in the treatment of complex or difficult wounds has been known since ancient times.

In recent years, the increase in life expectancy, the aging of the population and survival of chronically ill subjects lead to the outbreak of "hard to heal" wounds presenting multi drug resistant germs (MDR). Recent studies have shown that the effectiveness of thermal waters is not only related to the presence of dissolved ions but, as in the case of sulphurous ones, to the presence of hydrogen sulfide, a gas transmitter that diffuses freely through the skin, eliciting local and systemic effects. This molecule, present in sulphurous waters within specific pH and temperature ranges, is able to promote the healing of acute, chronic and infected wounds. H2S also exerts a powerful antibacterial and antifungal effect by transforming into pentationic acid (H2S5O6). In addition, the specific microbiome of each thermal source has the ability to interact with the skin microbiome and prevails over wound biofilm stimulating skin eubiosis. By virtue of these considerations, investigators perform an interventional pilot trial conducted to evaluate the effects of raw sulphurous thermal water, microbiologically pure, in the wound hygiene of acute and chronic wounds, regardless of their aetiology and bacterial colonization.

Outpatients \>18 years, presenting at spa facility with wound respecting selection criteria, will undergo to a wound hygiene protocol based on the use of raw sulphurous thermal water of Acque Albule, tested negative to microbiological analysis for the presence of pathogens. Subjects will be 1:1 randomized in 2 treatment arms: group A receiving sulphurous thermal water pack on soaked gauzes for 20 minutes and group B having their wound/s fully immersed in sulphurous thermal water for 20 minutes. Both arms will be treated every 48 hours up to complete wound re-epithelization. Participants will be submitted just at enrollment to wound microbiological sampling (swab). All parameters worth investigating will be assessed at each session prior to intervention (T0,2,4..) and after (T1,3,5...). Specifically wound microbiome sampling, together with pH, trans epidermal water loss (TEWL) measurements, wound fluorescence bacterial imaging, and ex-vivo microscope imaging will be recorded at each time point. Any adverse events, superinfections will be monitored and properly managed. A three months post-healing follow-up (Tf) will be performed to determine scar quality and possible wound relapse. Results will be expressed in term of intra-session (short term effects) and inter sessions(longitudinal effects) changes (delta) in order to assess the singular and the whole effects of each arm intervention. Finally differences in term of effectiveness among the two interventions will be evaluated.

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)

Primary outcomes:
measure: wound healing rate
timeFrame: within 10 minutes after wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
measure: Short term Wound bacteria critical colonization
timeFrame: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
measure: Short term Wound microbiome changes
timeFrame: within 10 minutes before and within 10 minutes after wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
measure: Short Term Wound bed pH changes
timeFrame: within 10 minutes before and within 10 minutes after wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Secondary outcomes:
measure: Longitudinal Wound microbiome changes during treatment up to re-epithelization
timeFrame: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
measure: Longitudinal Wound bacterial critical colonization control
timeFrame: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
measure: Longitudinal Wound bed pH changes
timeFrame: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
measure: Longitudinal Wound TEWL changes
timeFrame: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
measure: Long term re-epithelization stability
timeFrame: 90 days after wound healing (Tf)
Other outcomes:
measure: Microbiological wound sampling
timeFrame: at enrollment, day 0
measure: Effects of H2S rich water on wound biofilm integrity
timeFrame: within 10 minutes before and within 10 minutes after wound hygiene, each session, every 48 hours from day 0 up to wound re-epithelialization (up to 1 year)
measure: Short term differences among the two arms: administration of H2S could impact on the effectiveness of re-epithelization
timeFrame: within 10 minutes before and within 10 minutes after wound hygiene, each session, every 48 hours from day 0 up to wound re-epithelialization (up to 1 year)
measure: Longitudinal differences among the two arms
timeFrame: within 10 minutes before wound hygiene, each session, every 48 hours from day 0 up to wound re-epithelialization (up to 1 year)
Locations:
city: Bagni di Tivoli
country: Italy
facility: Terme di Roma Acque Albiule
state: Rome
Study officials:
affiliation: La Sapienza University of Rome
name: Serena Crucianelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Sapienza University of Rome
name: Mario Fontana, MD, PhD
role: STUDY_DIRECTOR
affiliation: Foro Italico University of Rome
name: Vincenzo Romano Spica, MD, PhD
role: STUDY_CHAIR
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