Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs

University Hospital, Geneva30 enrolled

Overview

In this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be based on standardised photographs and clinical data. The secondary objectives are to evaluate the tolerance and side effects of the honey based preparation in the management of chronic wounds.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leg Ulcer

Interventions

ApisSeptDEVICE

honey and ionic silver based dressing

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult * Chronic wounds due to arterial or venous insufficiency stages 1 to 3 and difficult to heal with the usual treatments and * Written informed consent Exclusion Criteria: * Refuse to give written informed consent. * Patient suffering from mental disorder that may interfere with the treatment. * Known allergy or intolerance to any of the products used in the formulation. * Having received systemic antibiotics within 7 days of starting treatment with honey based formulation. * Arterial insufficiency stage IV of the lower limbs.

Locations (1)

Home Care Service of the canton of Geneva

Geneva, Switzerland

Outcomes

Primary Outcomes

Granulation and /or epithelial tissue progression

Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).

Time frame: 8 weeks

Secondary Outcomes

Tolerance

Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.

Time frame: 8 weeks

Data from ClinicalTrials.gov

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