Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Study (Phase 2) to Evaluate the Safety, Tolerance and Efficacy of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs|
- Granulation and /or epithelial tissue progression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).
- Tolerance [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.
|Study Start Date:||January 2010|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
|Experimental: Honey and ionic silver dressing||
honey and ionic silver based dressing
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111695
|Home Care Service of the canton of Geneva|
|Principal Investigator:||Denis Salomon, Dr||Geneva University Hospital|