Status:
COMPLETED
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
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Inflammation
Burns
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, diabeti...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01214811
Start Date
September 1 2010
End Date
December 1 2011
Last Update
March 8 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute for advanced wound care
Momtgomery, Alabama, United States, 36111
2
Burn treatment center
Iowa City, Iowa, United States, 52242
3
Center for Curative & Palliative Care, Calvary Hospital
The Bronx, New York, United States, 10461