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Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns

NCT01418482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-06-05

Study results available
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Summary

The investigation is designed as an open, non-controlled, post-marketing investigation. Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will be included. The subject is allowed to have more than one burn on the body but only one should be included in the investigation. Each subject will be followed/assessed according to normal hospital routine 1-3 times per week for a maximum of 3 weeks or until desired treatment effect is obtained if that occurs earlier. All dressing changes will be done according to clinical routine and will follow the IFU (instruction for use). All dressing changes will be registered in a dressing log. Additional compression bandaging, gauze wrap, or such are allowed and should be reported as well

Conditions

  • Burns

Interventions

DEVICE

Mepilex Border Ag

a silver dressing

Sponsors & Collaborators

  • Molnlycke Health Care AB

    lead INDUSTRY

Principal Investigators

  • Fredrik Huss, MD · Akademiska Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01418482 on ClinicalTrials.gov