N/A Completed N=14 Treatment

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

Malignant wounds

Source: ClinicalTrials.gov NCT02431741 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcomePrimary: Infection in the Wound (Signs of Clinical Infection) — 14 participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Infection in the Wound (Signs of Clinical Infection)	14	—

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT02431741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.