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

Acute Wounds Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01164982
• Other study ID #: MPTO 02
• Status: Withdrawn
• Phase: N/A
• First received: July 16, 2010
• Last updated: April 27, 2015
• Start date: March 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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:

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Wounds

Intervention

Device:
• Mepitel One
Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier

Locations

Country	Name	City	State
Germany	Chir-Praxis	Hamburg	Hamm

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the handling of Mepitel® One when used in acute wounds in home care.		once a week for 3 weeks or until healing	No
Secondary	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	No