A Prospective, Open, Non-controlled Clinical Investigation to Evaluate the Performance and Safety of an Antimicrobial Foam Transferring Dressing in Patients With Malignant Wounds

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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This is a prospective, open, non-controlled clinical investigation to evaluate the performance and safety of using Mepilex Transfer Ag on a malignant wound. Approximately ten to fifteen (10-15) subjects from one to three centers in Europe, presenting with a malignant (fungating) wound will be enrolled into the study. Eligible subjects will have one malignant (fungating) wound selected as a "study site". Subjects will be followed for a one-week observation period with their existing product followed by a 4-week investigation period using Mepilex Transfer Ag.

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Detailed Description

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Conditions

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Malignant Wounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mepilex Transfer Ag

Non controlled investigation

Group Type EXPERIMENTAL

Mepilex Transfer Ag

Intervention Type DEVICE

Interventions

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Mepilex Transfer Ag

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Presence of at least one exuding malignant (fungating) wound in need for antimicrobial treatment
* Both genders with an age ≥ 18 years at randomization
* Subjects with a suspected survival time of \> 3 months
* Signed informed consent

Exclusion Criteria

* Any known or suspected systemic infection
* Use of metronidazole is not allowed during the investigation period
* Any known sensitivity to silver or other components/products used in this study.
* Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
* Participation in another investigational study while participating in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No