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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431741
• Other study ID #: MxT Ag 03
• Status: Completed
• Phase: N/A
• First received: April 28, 2015
• Last updated: April 18, 2017
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malignant Wounds
• Wounds and Injuries

Intervention

Device:
• Mepilex Transfer Ag

Locations

Country	Name	City	State
Czech Republic	Charles University School of Medicine	Prague
Czech Republic	The General University Hospital in Prague	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection in the Wound (Signs of Clinical Infection)	Weekly Visual inspection of the wounds by the investigators.	weekly, for 5 weeks