Clinical trial

Analgesic and Healing Effect of Topical Sevoflurane for Chronic Venous Ulcers

Name
Sevoflurane in ulcers
Description
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
Trial arms
Trial start
2022-05-02
Estimated PCD
2024-04-30
Trial end
2025-01-31
Status
Recruiting
Phase
Early phase I
Treatment
Sevoflurane
Topical application of 1 mL sevoflurane per 1 cm2 ulcer area once or two times daily.
Arms:
Topical sevoflurane
Other names:
Sevorane
Cyteal
Rinsing and cleaning of ulcer.
Arms:
Cyteal
Size
50
Primary endpoint
Pain intensity
Continuously for 5 days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Patient will separated by a screen from the treated area. Absorbent material with sevoflurane will be held under the distal pole of the wound to produce a typical smell of sevoflurane.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-09-06

1 organization

2 products

1 indication

Organization
Charles University
Indication
Leg Ulcer
Product
Cyteal