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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

CompletedPhase 3NCT01214811
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

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
Conditions
Interventions
  • Device: Mepilex Border Ag
Sponsor
Molnlycke Health Care AB
Start date
2010-09
Primary completion
2011-09
Sex
All
Age range
from 18 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
3

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01214811