Clinical trial NCT01214811: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Burns
Ulcers
Keywords: The change in signs of inflammation/local infection
To evaluate the comfort, conformability,
Pain during wear
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, diabetic foot and pressure ulcers) and partial thickness burns in need\* of topical antimicrobial treatment according to the physician.

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. 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)

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

Primary outcomes:
measure: Wound Are at Baseline
timeFrame: Baseline
measure: Wound Area at Visit 2
timeFrame: After one week
Secondary outcomes:
Other outcomes:
Locations:
city: Momtgomery
country: United States
facility: Institute for advanced wound care
state: Alabama
city: Iowa city
country: United States
facility: Burn treatment center
state: Iowa
city: Bronx
country: United States
facility: Center for Curative & Palliative Care, Calvary Hospital
state: New York
Study officials:
affiliation: UI burn Treatment Center,200 Hawkings Dr 8JCP Iowa City
name: Barbara Latenser, MD
role: PRINCIPAL_INVESTIGATOR
References: