Inflammation Clinical Trial
Official title:
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
Verified date | December 2011 |
Source | Molnlycke Health Care AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | December 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Center for Curative & Palliative Care, Calvary Hospital | Bronx | New York |
United States | Burn treatment center | Iowa city | Iowa |
United States | Institute for advanced wound care | Momtgomery | Alabama |
Lead Sponsor | Collaborator |
---|---|
Molnlycke Health Care AB |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound Are at Baseline | Baseline | No | |
Primary | Wound Area at Visit 2 | At each visit the wound length and width is measured and calculated in cm2. | After one week | No |
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