NCT02431741

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Wounds

Interventions

Type	Name	Description
DEVICE	Mepilex Transfer Ag

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2015-05-01
• Last updated: 2017-04-25
• Results posted: 2016-04-04

Locations

2 sites across 1 country: Czechia