N/A
N=14
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
Bottom Line
View on ClinicalTrials.gov: NCT02431741 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Infection in the Wound (Signs of Clinical Infection) — 14 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mepilex Transfer Ag (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infection in the Wound (Signs of Clinical Infection) |
14 | — |
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.
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.
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.