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

Molnlycke Health Care AB14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Wounds

Interventions

Mepilex Transfer Ag

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Charles University School of Medicine

Prague, Prague, Czechia

The General University Hospital in Prague

Prague, Prague, Czechia

Outcomes

Primary Outcomes

Infection in the Wound (Signs of Clinical Infection)

Weekly Visual inspection of the wounds by the investigators.

Time frame: weekly, for 5 weeks