Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
|ClinicalTrials.gov Identifier: NCT01111695|
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : September 30, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Leg Ulcer||Device: ApisSept||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2010|
|Primary Completion Date :||November 2010|
|Study Completion Date :||November 2010|
|Experimental: Honey and ionic silver dressing||
honey and ionic silver based dressing
- Granulation and /or epithelial tissue progression [ Time Frame: 8 weeks ]Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).
- Tolerance [ Time Frame: 8 weeks ]Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111695
|Home Care Service of the canton of Geneva|
|Principal Investigator:||Denis Salomon, Dr||Geneva University Hospital|