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

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

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.

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.