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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214811
• Other study ID #: MxB Ag 01
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2010
• Last updated: February 28, 2013
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Inflammation
• Signs and Symptoms
• Ulcer
• Ulcers

Intervention

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

Locations

Country	Name	City	State
United States	Center for Curative & Palliative Care, Calvary Hospital	Bronx	New York
United States	Burn treatment center	Iowa city	Iowa
United States	Institute for advanced wound care	Momtgomery	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Are at Baseline		Baseline	No
Primary	Wound Area at Visit 2	At each visit the wound length and width is measured and calculated in cm2.	After one week	No