Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care
The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds in home care.
Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||An Open Non-controlled Proof of Concept Investigation Evaluating the Handling of a Soft Silicone Wound Contact Layer, Mepitel® One Used in Acute Wounds in Home Care|
- to evaluate the handling of Mepitel® One when used in acute wounds in home care. [ Time Frame: once a week for 3 weeks or until healing ] [ Designated as safety issue: No ]
- to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events. [ Time Frame: once a week for 3 weeks or until healing ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||November 2010|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Device: Mepitel One
The investigation is designed as an open, non-controlled, proof of concept investigation. Subjects with acute wounds at one centre will be included. Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier. All dressing changes will be done according to clinical routine and registered in a dressing log. Cover dressing will be used when needed according to clinical routine.
A total of 10 subjects will be enrolled provided that they fulfil all the inclusion criteria and none of the exclusion criteria and have signed and dated the written informed consent.
The subjects will be consecutively allocated to a subject code.
At baseline, subject characteristics will be registered together with subject status of health, wound history and wound status, wound characteristics and current treatment of the wound.
The following variables will be measured as follows:
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164982
|Hamburg, Hamm, Germany, 59065|
|Principal Investigator:||Hans J Höning, Dr||Chir-Praxis, Hamburg|