Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing

Phase 3

Completed

• Conditions: Inflammation; Burns; Ulcers
• Interventions: Device: Mepilex Border Ag

• Registration Number: NCT01214811
• Lead Sponsor: Molnlycke Health Care AB

Brief Summary

The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need\* of topical antimicrobial treatment according to the physician.

Detailed Description

The investigation is designed as an open, non-controlled, post-marketing clinical follow-up. Subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. Each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. Each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. All dressing changes will be done according to clinical routine practices and will follow IFU (instruction for use)

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-04
• Study First Posted: 2010-10-05
• Primary Completion: 2011-09
• Status Verified: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2013-01-22
• Results First Submitted QC: 2013-01-22
• Results First Posted: 2013-02-26
• Last Update Submitted: 2013-02-28
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a partial thickness burn where an antimicrobial action is indicated* as judged by the investigator
• Male or female, 18 years and above, both in- and out-patients
• Signed Informed Consent Form

Exclusion Criteria

• Wound size equal to or above 9.5x15cm for the wound/burn to be included in the investigation
• Subject not expected to follow the investigation procedures
• TBSA > 10% (partial thickness burns only)
• HbA1C value > 7.2. (To be measured if BMI > 30)
• Pregnant and breastfeeding women
• Pressure ulcers deeper than stage 3
• Deep pressure ulcers in need of a filler
• Subjects with known sensitivity to silver or any other dressing materials
• Subjects receiving radiation treatment or examinations e.g. X-ray, ultrasound, diathermy or Magnetic Resonance Imaging
• Subjects using oxidising agents such as hypochlorite solutions or hydrogen peroxide
• Subjects previously included in this investigation
• Subjects included in other ongoing clinical investigation at present or during the past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mepilex Border Ag	Mepilex Border Ag	Non comparative study with one active arm - Mepilex Border Ag

Primary Outcome Measures

Name	Time	Method
Wound Are at Baseline	Baseline
Wound Area at Visit 2	After one week	At each visit the wound length and width is measured and calculated in cm2.

Trial Locations

Locations (3)

Institute for advanced wound care; 🇺🇸 Momtgomery, Alabama, United States

Center for Curative & Palliative Care, Calvary Hospital; 🇺🇸 Bronx, New York, United States

Burn treatment center; 🇺🇸 Iowa city, Iowa, United States