UlcersNCT06725797
Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene
A study testing wound hygiene with hypothermal sulfurous water by packs and wound hygiene with hypothermal sulfurous water by limb full immersion in people with Ulcers and Wound - in Medical Care, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcers, Wound - in Medical Care, Wounds and Injuries
- What is being tested?
- wound hygiene with hypothermal sulfurous water by packs and wound hygiene with hypothermal sulfurous water by limb full immersion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Study on the Effectiveness of Sulphurous Thermal Water in Wound Hygiene: Spa Wound Care
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.
Read the 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.
- Conditions
- Ulcers, Wound - in Medical Care, Wounds and Injuries, Wound Healing, Wound Care, Venous Ulcers
- Being tested
- wound hygiene with hypothermal sulfurous water by packs, wound hygiene with hypothermal sulfurous water by limb full immersion
- Keywords
- wound hygiene, chronic wound, sulfurous water, spa thermal water, wound care
- Medical subject headings
- Ulcer, Wounds and Injuries, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound hygiene with hypothermal sulfurous water by packsProcedure or surgery
Also called wound hygiene by packs
GROUP A: After dressing removal, the wound is exposed. Sulphur thermal water at spring temperature (23°C) is applied for 20 minutes on the untreated wound by packs on non woven gauzes entirely covering the area. Eventually, if dried, gauzes are externally watered with additional sulphurous thermal water during the 20 minutes. After water application the wound follows the other 3 steps of the wound hygiene protocol: non viable tissue removal, edges reactivation and dressing. Non interactive dressings, just for wound moisture management, are used on cleaned wound/s. Dressing fixation, elastic bandages or off-load will be provided when required. the intervention will be repeated every 48 hours for both arms.
wound hygiene with hypothermal sulfurous water by limb full immersionProcedure or surgery
Also called wound hygiene by limb full immersion
GROUP B: After dressing removal, the wound is exposed. Sulphur thermal water at spring temperature (23°C) is applied for 20 minutes on the untreated wound by limb full immersion in a limb tub. After the immersion, the wound follows the other 3 steps of the wound hygiene protocol: non viable tissue removal, edges reactivation and dressing. Non interactive dressings, just for wound moisture management, are used on cleaned wound/s. Dressing fixation, elastic bandages or off-load will be provided when required. the intervention will be repeated every 48 hours for both arms.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A:wound hygiene with spa thermal sulphurous water delivered with pack on soaked gauzes | Active comparator | 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). Receives: Procedure: wound hygiene with hypothermal sulfurous water by packs |
| GROUP B: limb full immersion in spa thermal sulphurous water | Active comparator | 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). Receives: Procedure: wound hygiene with hypothermal sulfurous water by limb full immersion |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound healing rate
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.
Measured: within 10 minutes after wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Short term Wound bacteria critical colonization
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
Measured: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Short term Wound microbiome changes
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)
Measured: 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)
Short Term Wound bed pH changes
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)
Measured: 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 (5)
Longitudinal Wound microbiome changes during treatment up to re-epithelization
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).
Measured: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Longitudinal Wound bacterial critical colonization control
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.
Measured: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Longitudinal Wound bed pH changes
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).
Measured: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Longitudinal Wound TEWL changes
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
Measured: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Long term re-epithelization stability
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).
Measured: 90 days after wound healing (Tf)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start20 Oct 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for UlcersStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli studi di Roma Foro Italico
- Responsible party
- Principal investigator, Mario Fontana, University of Roma La Sapienza
- Investigators
- Serena Crucianelli, MD, Principal investigator, La Sapienza University of RomeMario Fontana, MD, PhD, Study director, La Sapienza University of RomeVincenzo Romano Spica, MD, PhD, Study chair, Foro Italico University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725797
- Sponsor's protocol ID
- VULNOLOGIATERMALE1
- Other IDs
- AR12419075FF92A2
- Status last verified
- Dec 2024
- First submitted
- 11 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: raw data not containing any tracking sensible data (whole data) will be shared for publishing and at authorized medical conferences
Publications
Tsuji, Hideo.
Faga A, Nicoletti G, Gregotti C, Finotti V, Nitto A, Gioglio L. Effects of thermal water on skin regeneration. Int J Mol Med. 2012 May;29(5):732-40. doi: 10.3892/ijmm.2012.917. Epub 2012 Feb 15.
PubMed 22344563Davidelli S, Bassetto F, Vitale M, Scapagnini G. Thermal Waters and the hormetic effects of hydrogen Sulfide on inflammatory arthritis and wound healing. Chapter 10 elsevier https://www.sciencedirect.com/science/article/pii/B9780128142530000103
Wallace JL, Dicay M, McKnight W, Martin GR. Hydrogen sulfide enhances ulcer healing in rats. FASEB J. 2007 Dec;21(14):4070-6. doi: 10.1096/fj.07-8669com. Epub 2007 Jul 18.
PubMed 17634391Mormile I, Tuccillo F, Della Casa F, D'Aiuto V, Montuori N, De Rosa M, Napolitano F, de Paulis A, Rossi FW. The Benefits of Water from Nitrodi's Spring: The In Vitro Studies Leading the Potential Clinical Applications. Int J Mol Sci. 2023 Sep 5;24(18):13685. doi: 10.3390/ijms241813685.
PubMed 37761993Napolitano F, Postiglione L, Mormile I, Barrella V, de Paulis A, Montuori N, Rossi FW. Water from Nitrodi's Spring Induces Dermal Fibroblast and Keratinocyte Activation, Thus Promoting Wound Repair in the Skin: An In Vitro Study. Int J Mol Sci. 2023 Mar 10;24(6):5357. doi: 10.3390/ijms24065357.
PubMed 36982430Ahmad A, Druzhyna N, Szabo C. Effect of 3-mercaptopyruvate Sulfurtransferase Deficiency on the Development of Multiorgan Failure, Inflammation, and Wound Healing in Mice Subjected to Burn Injury. J Burn Care Res. 2019 Feb 20;40(2):148-156. doi: 10.1093/jbcr/irz007.
PubMed 30649358Benedetti F, Curreli S, Krishnan S, Davinelli S, Cocchi F, Scapagnini G, Gallo RC, Zella D. Anti-inflammatory effects of H2S during acute bacterial infection: a review. J Transl Med. 2017 May 10;15(1):100. doi: 10.1186/s12967-017-1206-8.
PubMed 28490346Sheng L, Zhang Z, Zhang Y, Wang E, Ma B, Xu Q, Ma L, Zhang M, Pei G, Chang J. A novel "hot spring"-mimetic hydrogel with excellent angiogenic properties for chronic wound healing. Biomaterials. 2021 Jan;264:120414. doi: 10.1016/j.biomaterials.2020.120414. Epub 2020 Sep 19.
PubMed 32980635Han X, Wang L, Shang Y, Liu X, Yuan J, Shen J. Hydrogen sulfide-releasing polyurethane/gelatin/keratin-TA conjugate mats for wound healing. J Mater Chem B. 2022 Nov 3;10(42):8672-8683. doi: 10.1039/d2tb01700h.
PubMed 36250498Wu J, Chen A, Zhou Y, Zheng S, Yang Y, An Y, Xu K, He H, Kang J, Luckanagul JA, Xian M, Xiao J, Wang Q. Novel H2S-Releasing hydrogel for wound repair via in situ polarization of M2 macrophages. Biomaterials. 2019 Nov;222:119398. doi: 10.1016/j.biomaterials.2019.119398. Epub 2019 Aug 16.
PubMed 31487582Wu J, Li Y, He C, Kang J, Ye J, Xiao Z, Zhu J, Chen A, Feng S, Li X, Xiao J, Xian M, Wang Q. Novel H2S Releasing Nanofibrous Coating for In Vivo Dermal Wound Regeneration. ACS Appl Mater Interfaces. 2016 Oct 19;8(41):27474-27481. doi: 10.1021/acsami.6b06466. Epub 2016 Oct 7.
PubMed 27504858Zhang Y, Yue T, Gu W, Liu A, Cheng M, Zheng H, Bao D, Li F, Piao JG. pH-responsive hierarchical H2S-releasing nano-disinfectant with deep-penetrating and anti-inflammatory properties for synergistically enhanced eradication of bacterial biofilms and wound infection. J Nanobiotechnology. 2022 Jan 29;20(1):55. doi: 10.1186/s12951-022-01262-7.
PubMed 35093073Cremonini, V., Giuliani, R., Fusaroli, P., & Rubbi, I. Valutazione e monitoraggio delle ferite difficili con l'utilizzo della scala Bates-Jensen Assessment Tool: studio osservazionale. - DERMATOLOGICAL EXPERIENCES 2017;19:1-2. DOI: 10.23736/S1128-9155.17.00446-0
Pinnagoda J, Tupker RA, Agner T, Serup J. Guidelines for transepidermal water loss (TEWL) measurement. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1990 Mar;22(3):164-78. doi: 10.1111/j.1600-0536.1990.tb01553.x.
PubMed 2335090
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effectiveness of Sulphurous Thermal Water in Wound Hygiene: Spa Wound Care
- ClinicalTrials.gov ID
- NCT06725797
- Acronym / sponsor ID
- VULNOLOGIATERMALE1
- Conditions
- Ulcers, Wound - in Medical Care, Wounds and Injuries, Wound Healing, Wound Care, Venous Ulcers
- Keywords
- wound hygiene, chronic wound, sulfurous water, spa thermal water, wound care
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- Università degli studi di Roma Foro Italico
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| GROUP A:wound hygiene with spa thermal sulphurous water delivered with pack on soaked gauzes | Active comparator | Procedure: wound hygiene with hypothermal sulfurous water by packsnon woven gauzes will be soaked with sulphurous thermal water and positioned on the wound as packs for 20 minutes, at spring temperature (23°C). |
| GROUP B: limb full immersion in spa thermal sulphurous water | Active comparator | Procedure: wound hygiene with hypothermal sulfurous water by limb full immersionfull 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wound hygiene with hypothermal sulfurous water by packsAlso: wound hygiene by packsGROUP A: After dressing removal, the wound is exposed. Sulphur thermal water at spring temperature (23°C) is applied for 20 minutes on the untreated wound by packs on non woven gauzes entirely covering the area. Eventually, if dried, gauzes are externally watered with additional sulphurous thermal water during the 20 minutes. After water application the wound follows the other 3 steps of the wound hygiene protocol: non viable tissue removal, edges reactivation and dressing. Non interactive dressings, just for wound moisture management, are used on cleaned wound/s. Dressing fixation, elastic bandages or off-load will be provided when required. the intervention will be repeated every 48 hours for both arms. | Procedure or surgery | GROUP A:wound hygiene with spa thermal sulphurous water delivered with pack on soaked gauzes |
| wound hygiene with hypothermal sulfurous water by limb full immersionAlso: wound hygiene by limb full immersionGROUP B: After dressing removal, the wound is exposed. Sulphur thermal water at spring temperature (23°C) is applied for 20 minutes on the untreated wound by limb full immersion in a limb tub. After the immersion, the wound follows the other 3 steps of the wound hygiene protocol: non viable tissue removal, edges reactivation and dressing. Non interactive dressings, just for wound moisture management, are used on cleaned wound/s. Dressing fixation, elastic bandages or off-load will be provided when required. the intervention will be repeated every 48 hours for both arms. | Procedure or surgery | GROUP B: limb full immersion in spa thermal sulphurous water |
Primary outcome
wound healing rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
5 secondary outcomes
Longitudinal Wound microbiome changes during treatment up to re-epithelization
Time frame: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Longitudinal Wound bacterial critical colonization control
Time frame: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Longitudinal Wound bed pH changes
Time frame: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Longitudinal Wound TEWL changes
Time frame: within 10 minutes before wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)
Long term re-epithelization stability
Time frame: 90 days after wound healing (Tf)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- BackgroundTsuji, Hideo.
- Background: PubMed 22344563Faga A, Nicoletti G, Gregotti C, Finotti V, Nitto A, Gioglio L. Effects of thermal water on skin regeneration. Int J Mol Med. 2012 May;29(5):732-40. doi: 10.3892/ijmm.2012.917. Epub 2012 Feb 15.
- BackgroundDavidelli S, Bassetto F, Vitale M, Scapagnini G. Thermal Waters and the hormetic effects of hydrogen Sulfide on inflammatory arthritis and wound healing. Chapter 10 elsevier https://www.sciencedirect.com/science/article/pii/B9780128142530000103
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- Individual participant dataSharing planned: No. raw data not containing any tracking sensible data (whole data) will be shared for publishing and at authorized medical conferences
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Serena Crucianelli, MD principal investigator
La Sapienza University of Rome
Mario Fontana, MD, PhD study director
La Sapienza University of Rome
Vincenzo Romano Spica, MD, PhD study chair
Foro Italico University of Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wound hygiene with hypothermal sulfurous water by packs and wound hygiene with hypothermal sulfurous water by limb full immersion in people with Ulcers and Wound - in Medical Care, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound healing rate (time frame: within 10 minutes after wound hygiene, each session, every 48 hours, from day 0 up to wound re-epithelialization (up to 1 year)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06725797, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.