NCT01164982

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2010

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

April 28, 2015

Status Verified

December 1, 2010

Enrollment Period

5 months

First QC Date

July 16, 2010

Last Update Submit

April 27, 2015

Conditions

Acute Wounds

Outcome Measures

Primary Outcomes (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 Outcomes (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

Interventions

Mepitel OneDEVICE

Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute wounds/burns
  • Male or female, 18 years and above, both in- and outpatients.
  • Signed Informed Consent Form

You may not qualify if:

  • Wound size above 21x24.5 cm
  • Subject not expected to follow the investigation procedures
  • Subjects previously included in this investigation
  • Subjects included in other ongoing clinical investigation at present or during the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chir-Praxis

Hamburg, Hamm, 59065, Germany

Location

Study Officials

  • Hans J Höning, Dr

    Chir-Praxis, Hamburg

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 16, 2010

First Posted

July 19, 2010

Study Start

March 1, 2010

Primary Completion

August 1, 2010

Study Completion

November 1, 2010

Last Updated

April 28, 2015

Record last verified: 2010-12

Locations

DE(1)