Phase 3
N=27
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
Inflammation · Burns · Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT01214811 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Wound Are at Baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mepilex Border Ag (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Are at Baseline |
— | — |
| PRIMARY Wound Area at Visit 2 |
43.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01214811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.