Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care
|ClinicalTrials.gov Identifier: NCT01164982|
Recruitment Status : Withdrawn (No resources available at the clinic)
First Posted : July 19, 2010
Last Update Posted : April 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Wounds||Device: Mepitel One||Not Applicable|
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:
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||November 2010|
- Device: Mepitel One
Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164982
|Hamburg, Hamm, Germany, 59065|
|Principal Investigator:||Hans J Höning, Dr||Chir-Praxis, Hamburg|