Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene
NCT ID: NCT06725797
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2024-10-20
2024-12-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Epidemiological and statistic assessors are blinded to arm randomization list as well.
Study Groups
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GROUP A:wound hygiene with spa thermal sulphurous water delivered with pack on soaked gauzes
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).
wound hygiene with hypothermal sulfurous water 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.
GROUP B: limb full immersion in spa thermal sulphurous water
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).
wound hygiene with hypothermal sulfurous water 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.
Interventions
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wound hygiene with hypothermal sulfurous water 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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Università degli studi di Roma Foro Italico
OTHER
University of Roma La Sapienza
OTHER
Responsible Party
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Mario Fontana
MD, PhD, Associate Professor
Principal Investigators
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Serena Crucianelli, MD
Role: PRINCIPAL_INVESTIGATOR
La Sapienza University of Rome
Mario Fontana, MD, PhD
Role: STUDY_DIRECTOR
La Sapienza University of Rome
Vincenzo Romano Spica, MD, PhD
Role: STUDY_CHAIR
Foro Italico University of Rome
Locations
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Terme di Roma Acque Albiule
Bagni di Tivoli, Rome, Italy
Countries
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References
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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.
Davidelli 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.
Mormile 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.
Napolitano 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.
Ahmad 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.
Benedetti 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.
Sheng 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.
Han 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.
Wu 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.
Wu 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.
Zhang 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.
Cremonini, 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.
Schneider LA, Korber A, Grabbe S, Dissemond J. Influence of pH on wound-healing: a new perspective for wound-therapy? Arch Dermatol Res. 2007 Feb;298(9):413-20. doi: 10.1007/s00403-006-0713-x. Epub 2006 Nov 8.
Wilson IA, Henry M, Quill RD, Byrne PJ. The pH of varicose ulcer surfaces and its relationship to healing. Vasa. 1979;8(4):339-42. No abstract available.
Toriyama T, Kumada Y, Matsubara T, Murata A, Ogino A, Hayashi H, Nakashima H, Takahashi H, Matsuo H, Kawahara H. Effect of artificial carbon dioxide foot bathing on critical limb ischemia (Fontaine IV) in peripheral arterial disease patients. Int Angiol. 2002 Dec;21(4):367-73.
Zhao H, Lu S, Chai J, Zhang Y, Ma X, Chen J, Guan Q, Wan M, Liu Y. Hydrogen sulfide improves diabetic wound healing in ob/ob mice via attenuating inflammation. J Diabetes Complications. 2017 Sep;31(9):1363-1369. doi: 10.1016/j.jdiacomp.2017.06.011. Epub 2017 Jun 30.
Crucianelli, S., Fontana, M., Moretti, F., Cocomello, N., Mariano, A., & DEL BEN, M. (2024). PILOT STUDY ON THE EFFECTIVENESS OF SULFUROUS THERMAL WATER IN WOUND HYGIENE: SPA WOUND CARE. In The 24th Annual Meeting of the European Pressure Ulcer Advisory Panel Abstract book (pp. 81-81).
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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AR12419075FF92A2
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
VULNOLOGIATERMALE1
Identifier Type: -
Identifier Source: org_study_id