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

NCT01214811 | Completed Phase 3 Results

• 1 other identifier: MxB Ag 01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

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.

Conditions

Inflammation; Burns; Ulcers

Keywords

The change in signs of inflammation/local infection; To evaluate the comfort, conformability,; Pain during wear

Outcome Measures

Primary Outcomes (2)

• Wound Are at Baseline

  Baseline

• Wound Area at Visit 2

  At each visit the wound length and width is measured and calculated in cm2.

  After one week

Study Arms (1)

Mepilex Border Ag

OTHER

Non comparative study with one active arm - Mepilex Border Ag

Device: Mepilex Border Ag

Interventions

Mepilex Border Ag DEVICE

Mepilex Border Ag may be left in place for up to seven days, depending on the condition.

Mepilex Border Ag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (3)

Institute for advanced wound care

Momtgomery, Alabama, 36111, United States

Location

Burn treatment center

Iowa City, Iowa, 52242, United States

Location

Center for Curative & Palliative Care, Calvary Hospital

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Inflammation; Burns; Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Results Point of Contact

• Title: Viktoria Ahlenius Körner
• Organization: Molnlycke Health Care

viktoria.ahleniuskorner@molnlycke.com

0046 31 7223000

Study Officials

• Barbara Latenser, MD

  UI burn Treatment Center,200 Hawkings Dr 8JCP Iowa City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 5, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 8, 2013
• Results First Posted: February 26, 2013

Record last verified: 2011-12

Locations

US (3)