Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene

University of Roma La Sapienza

Status: Invitation-only

Conditions: Wound Care; Venous Ulcers; Wound Healing; Wound Cleansing; Ulcers; Wounds and Injuries; Wound - in Medical Care

Treatments: Procedure: wound hygiene with hypothermal sulfurous water by limb full immersion; Procedure: wound hygiene with hypothermal sulfurous water by packs

Study type: Interventional

Funder types: Other

Identifiers

NCT06725797

AR12419075FF92A2 (Other Grant/Funding Number)

VULNOLOGIATERMALE1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

GROUP A:wound hygiene with spa thermal sulphurous water delivered with pack on soaked gauzes

Active Comparator group

Description:

non woven gauzes will be soaked with sulphurous thermal water and positioned on the wound as packs for 20 minutes, at spring temperature (23°C).

Treatment:

Procedure: wound hygiene with hypothermal sulfurous water by packs

GROUP B: limb full immersion in spa thermal sulphurous water

Active Comparator group

Description:

full wound immersion: the limb hosting the wound is located in a limb-sized tube filled with sulphurous water for 20 minutes at spring temperature (23°C).

Treatment:

Procedure: wound hygiene with hypothermal sulfurous water by limb full immersion