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

Not Applicable

Completed

• Conditions: Malignant Wounds
• Interventions: Device: Mepilex Transfer Ag

• Registration Number: NCT02431741
• Lead Sponsor: Molnlycke Health Care AB

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Status Verified: 2015-04
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-04-30
• Study First Posted: 2015-05-01
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Results First Submitted: 2016-03-04
• Results First Submitted QC: 2016-03-04
• Results First Posted: 2016-04-04
• Last Update Submitted: 2017-04-18
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mepilex Transfer Ag	Mepilex Transfer Ag	Non controlled investigation

Primary Outcome Measures

Name	Time	Method
Infection in the Wound (Signs of Clinical Infection)	weekly, for 5 weeks	Weekly Visual inspection of the wounds by the investigators.

Trial Locations

Locations (2)

The General University Hospital in Prague; 🇨🇿 Prague, Czech Republic

Charles University School of Medicine; 🇨🇿 Prague, Czech Republic