Clinical trial NCT05303805: Topical Sevoflurane for Treatment of Chronic Leg Ulcers
Official title: Analgesic and Healing Effect of Topical Sevoflurane for Chronic Venous Ulcers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Leg Ulcer
Keywords: Leg Ulcer
Sevoflurane
Pain
Healing ulcer
Microbial colonization
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: Faculty Hospital Kralovske Vinohrady
First posted: 2022-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group will have sevoflurane applied at approximately 1 ml/cm2 at the start of wound treatment, the control group will only have a standard rinse solution with , with sevoflurane used to soak the absorbent material held under the distal pole of the wound to produce a typical smell of sevoflurane.
Primary purpose: TREATMENT

Brief summary: Patients with painful non-healing leg ulcer will be enrolled in the clinical single-blinded randomized study. The active treatment group will have sevoflurane applied at approximately 1 ml/cm2 at the start of wound treatment, the control group will only have a standard rinse solution with Cyteal TM (Pierre Fabre Medicament, France). Further treatment will then be carried out in the standard manner. The duration of the study will be 5 days; if the defect heals earlier, it will be terminated early.

Exclusion criteria: allergy to sevoflurane, inability to understand the questionnaire

Parameters to be monitored will be pain intensity, microbial colonization, appearance and size of the defect

Detailed description: A prospective single-blinded randomized study will be conducted in patients of the Dermatovenereology Clinic of the 3rd Medical Faculty of Charles University (3LF UK) and the University Hospital Kralovske Vinohrady (FNKV) with painful non-healing tibial ulcers. Pain intensity on a numerical rating scale (NRS 0-10) must be NRS\>4. The envelope method will be used for randomization. To blind patients, therapy will be performed by separating patients with a drape from the treatment area of the body. As sevoflurane has a typical odor, it will only be used in the control group to soak up absorbent material held under the distal pole of the wound without skin contact. In the active treatment group, sevoflurane will be applied at the beginning of the wound treatment at approximately 1 ml/cm2 of the ulcer surface. The standard therapy used in the control group will use only Cyteal TM lavage solution, which contains hexamidine diisetione 100 mg in 100 ml, chlorhexidine digluconate 20% solution 100 mg and chlorocresol 300 mg.

The primary aim of the study will be pain relief after sevoflurane therapy. Pain intensity will be measured by NRS at 1-hour intervals (excluding sleep); decrease of 2 point for at least 4 hours will be considered significant. Secondary aim will be healing of ulcers. The effect will be controlled by elimination of pathologic microbial colonization, cleaning of the base of the wound and decreasing the size of the ulcer. Microbial colonization will be measured by microbial swab culture before application, after the 1st application before dressing and on the 5th day after application), the appearance of the defect base will be assessed by the appearance of the surface, the size of the defect will be measured in cm2.

Eligibility criteria: Inclusion Criteria:

* Patients with painful (pain intensity on the numerical scale NRS 0-10 is NRS\>4) non- healing tibial venous ulcers

Exclusion Criteria:

* Allergy to sevoflurane
* Inability to understand the pain-intensity questionnaire

Primary outcomes:
measure: Pain intensity
timeFrame: Continuously for 5 days
Secondary outcomes:
measure: Microbial colonization
timeFrame: Before application of treatment, after the 1st application before tibial coverage and on the 5th day after application
measure: Size of skin defect
timeFrame: 5 days
measure: Appearance of the ulcer bed
timeFrame: 5 days
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
Study officials:
affiliation: 3rd Medical Faculty of Charles University
name: Jiří Málek, M.D.
role: PRINCIPAL_INVESTIGATOR
References: