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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Burns; Ulcers
• Intervention / Treatment: Device: Mepilex Border Ag

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Momtgomery, Alabama, United States, 36111
      • Institute for Advanced Wound Care
  • Iowa
    • Iowa city, Iowa, United States, 52242
      • Burn treatment center
  • New York
    • Bronx, New York, United States, 10461
      • Center for Curative & Palliative Care, Calvary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mepilex Border Ag; Non comparative study with one active arm - Mepilex Border Ag	Device: Mepilex Border Ag; Mepilex Border Ag may be left in place for up to seven days, depending on the condition.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Barbara Latenser, MD, UI burn Treatment Center,200 Hawkings Dr 8JCP Iowa City

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 4, 2010
• First Submitted That Met QC Criteria: October 4, 2010
• First Posted (Estimate): October 5, 2010

Study Record Updates

• Last Update Posted (Estimate): March 8, 2013
• Last Update Submitted That Met QC Criteria: February 28, 2013
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: The change in signs of inflammation/local infection; To evaluate the comfort, conformability,; Pain during wear
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Burns; Ulcer; Inflammation; Infections
• Other Study ID Numbers: MxB Ag 01