RecruitingPhase 4NCT05303805

Topical Sevoflurane for Treatment of Chronic Leg Ulcers

Analgesic and Healing Effect of Topical Sevoflurane for Chronic Venous Ulcers


Sponsor

Charles University, Czech Republic

Enrollment

50 participants

Start Date

May 2, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria2

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

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Interventions

DRUGSevoflurane

Topical application of 1 mL sevoflurane per 1 cm2 ulcer area once or two times daily.

COMBINATION_PRODUCTCyteal

Rinsing and cleaning of ulcer.


Locations(1)

Faculty Hospital Kralovske Vinohrady

Prague, Czechia

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NCT05303805


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