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临床试验/NCT06725797
NCT06725797Enrolling By Invitation不适用

Pilot Study on the Effectiveness of Sulphurous Thermal Water in Wound Hygiene: Spa Wound Care

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
2
主要终点
wound healing rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Microbiological and microbiome assessors are blinded to subjects' treatment or arm randomization list.

Epidemiological and statistic assessors are blinded to arm randomization list as well.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

wound healing rate

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

次要结局

  • 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))
  • 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))
  • 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))
  • 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))
  • Long term re-epithelization stability(90 days after wound healing (Tf))

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Fontana

MD, PhD, Associate Professor

University of Roma La Sapienza

研究点 (2)

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