Study on the Effectiveness of Hypothermal Sulphurous Water in Wound Hygiene

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.

Conditions

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

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

• Università degli studi di Roma Foro Italico

  collaborator OTHER

• University of Roma La Sapienza

  lead OTHER

Principal Investigators

• Serena Crucianelli, MD · La Sapienza University of Rome

• Mario Fontana, MD, PhD · La Sapienza University of Rome

• Vincenzo Romano Spica, MD, PhD · Foro Italico University of Rome

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-20

Primary Completion

2024-12-30

Completion

2024-12-30

Countries

• Italy

Study Locations