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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Inflammation Burns Ulcers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mepilex Border Ag

Non comparative study with one active arm - Mepilex Border Ag

Group Type OTHER

Mepilex Border Ag

Intervention Type DEVICE

Mepilex Border Ag may be left in place for up to seven days, depending on the condition.

Interventions

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Mepilex Border Ag

Mepilex Border Ag may be left in place for up to seven days, depending on the condition.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No