Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene

Not Applicable

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

• Registration Number: NCT06725797
• Lead Sponsor: University of Roma La Sapienza

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.

Study Timeline

• Study Start: 2024-10-20
• Study First Submitted: 2024-11-11
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
wound healing rate	within 10 minutes after wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)	Longitudinal Wound healing rate will be assessed at each dressing change by applying Bates Jansen Wound Tool Score (BWAT)., max score 65, min 13, The HIGHER the total score, the more severe the wound status.
Short term Wound bacteria critical colonization	within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)	The fluorescence wound imaging using Moleculight device, assessing critical bacterial colonization (\>104UFC) of the wound before intervention will be compared to that obtained after intervention to determine whether 20 minutes exposure to sulphurous water could have exerted an antibacterial activity. The HIGHER the luminescence, the more severe the wound critical colonization
Short term Wound microbiome changes	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)	Wound microbiome changes will be determined before treatment, immediately after the wound hygiene in order to assess its variation related to sulfurous hypothermal water exposure .(analysis of 16S ribosomial rNa sub-unit)
Short Term Wound bed pH changes	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)	Ph of the wound bed will be measured using a flat glass cleavable probe, before and after intervention in order to detect if 20 minutes exposure to soaked gauzes in H2S rich water are enough to determine a lowering in wound pH values.(according to pH scale 0 to 10)

Secondary Outcome Measures

Name	Time	Method
Longitudinal Wound microbiome changes during treatment up to re-epithelization	within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)	Wound microbiome changes will be determined comparing samples collected before intervention every 48 hours in order to assess inter sessions quantitative and qualitative changes related to sulfurous hypothermal water exposure (analysis of 16S risosomial rNA sub-units).
Longitudinal Wound bacterial critical colonization control	within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)	Referring to the microbiological swab performed at enrollment on day 0, The fluorescence wound imaging using Moleculight device,will monitor any eventual inter session changes in critical bacterial colonization of the wound up to re-epithelization.The HIGHER the total wound luminescence, the more severe the wound bacterial colonization.
Longitudinal Wound bed pH changes	within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)	Ph of the wound bed, measured using a flat glass cleavable probe, at each session , before the exposure to H2S rich water are compared in order to assess an inter session lowering trend of wound pH (pH scale from 0 to 10).
Longitudinal Wound TEWL changes	within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)	TEWL (TRANS EPIDERMAL WATER LOSS) of the wounded skin will be measured in g hm -2 ,using a closed chamber device, at each session, before the intervention. The inter session values obtained will be compared to assess an eventual lowering trend of TEWL values, a sign of recovery of skin integrity typically associated to wound re-epithelization . Normal values are considered ranging from 0 to 15 g hm -2 ). The HIGHER the TEWL score, the more severe the skin breakdown
Long term re-epithelization stability	90 days after wound healing (Tf)	Wound area integrity and neo-epithelium stability (by skin plication manoeuvre) are evaluated 90 days after complete wound healing together with any wound relapse (physical examination: presence Vs absence).

Trial Locations

Locations (1)

Terme di Roma Acque Albiule; 🇮🇹 Bagni di Tivoli, Rome, Italy