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OpenTrials
Completed

NCT Number: NCT02431741

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

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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Key information

Conditions

Malignant Wounds

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charles University School of Medicine, Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mepilex Transfer Ag

Device

Primary outcomes

  1. Infection in the Wound (Signs of Clinical Infection)

    Time frame: weekly, for 5 weeks

    Weekly Visual inspection of the wounds by the investigators.

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 1, 2015
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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