Topical Sevoflurane for Treatment of Chronic Leg Ulcers

Analgesic and Healing Effect of Topical Sevoflurane for Chronic Venous Ulcers

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

Study Overview

• Status: Recruiting
• Conditions: Leg Ulcer
• Intervention / Treatment: Drug: Sevoflurane; Combination product: Cyteal

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jiri Malek, M.D.; Phone Number: +4202671622461; Email: malekj@fnkv.cz
• Study Contact Backup: Name: Jiri Malek, M.D.; Phone Number: +4202671622272461; Email: malekj@fnkv.cz

Study Locations

• Czechia
  • Praha, Czechia, 100 00
    • Recruiting
    • Faculty Hospital Kralovske Vinohrady
    • Contact: Jiri Malek, M.D.
    • Sub-Investigator: Spyridon Gkalpakiotis, M.D.
    • Sub-Investigator: Alice Kurzova, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical sevoflurane; The active treatment group will have sevoflurane applied at approximately 1 ml/cm2 at the start of wound treatment,	Drug: Sevoflurane; Topical application of 1 mL sevoflurane per 1 cm2 ulcer area once or two times daily.; Other Names: Sevorane
Active Comparator: Cyteal; the control group will only have a standard rinse solution with Cyteal PIERRE FABRE MEDICAMENT, France (100 ml of skin fluid contains hexamidine diisetione 100 mg, chlorohexidine digluconate (solutio 20 %) 100 mg and chlorocresol 300 mg), with sevoflurane used to soak the absorbent material held under the distal pole of the wound.	Combination product: Cyteal; Rinsing and cleaning of ulcer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity measured by numeric rating scale (NRS) from 0 - no pain (the best result) to 10 - the worst possible pain using a standard questionnaire	Continuously for 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial colonization	Microbial smear for culture	Before application of treatment, after the 1st application before tibial coverage and on the 5th day after application
Size of skin defect	Measured in cm2	5 days
Appearance of the ulcer bed	Epithelial tissue, granulation tissue, slough, necrotic tissue	5 days

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Collaborators: Faculty Hospital Kralovske Vinohrady
• Investigators: Principal Investigator: Jiří Málek, M.D., 3rd Medical Faculty of Charles University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: February 27, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 2, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Sevoflurane; Leg Ulcer; Healing ulcer; Microbial colonization
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Leg Ulcer; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: Sevoflurane in ulcers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No