Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care

• Sponsor: Molnlycke Health Care AB (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT01164982
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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	N/A

Detailed Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• 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: Mar 1, 2010
• Anticipated Primary Completion Date: Aug 1, 2010
• Anticipated Study Completion Date: Nov 1, 2010

Outcome Measures

Primary Outcome Measures

1. to evaluate the handling of Mepitel® One when used in acute wounds in home care. [once a week for 3 weeks or until healing]

Secondary Outcome Measures

1. to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing and adverse events. [once a week for 3 weeks or until healing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Acute wounds/burns

2. Male or female, 18 years and above, both in- and outpatients.

3. Signed Informed Consent Form

Exclusion Criteria:

1. Wound size above 21x24.5 cm

2. Subject not expected to follow the investigation procedures

3. Subjects previously included in this investigation

4. Subjects included in other ongoing clinical investigation at present or during the past 30 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chir-Praxis	Hamburg	Hamm	Germany	59065

Sponsors and Collaborators

• Molnlycke Health Care AB

Investigators

• Principal Investigator: Hans J Höning, Dr, Chir-Praxis, Hamburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01164982
• Other Study ID Numbers: MPTO 02
• First Posted: Jul 19, 2010
• Last Update Posted: Apr 28, 2015
• Last Verified: Dec 1, 2010

• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Apr 28, 2015