search
Back to results

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

Primary Purpose

Inflammation, Burns, Ulcers

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Mepilex Border Ag
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation focused on measuring The change in signs of inflammation/local infection, To evaluate the comfort, conformability,, Pain during wear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for advanced wound care
  • Burn treatment center
  • Center for Curative & Palliative Care, Calvary Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Mepilex Border Ag

Arm Description

Non comparative study with one active arm - Mepilex Border Ag

Outcomes

Primary Outcome Measures

Wound Are at Baseline
Wound Area at Visit 2
At each visit the wound length and width is measured and calculated in cm2.

Secondary Outcome Measures

Full Information

First Posted
October 4, 2010
Last Updated
February 28, 2013
Sponsor
Molnlycke Health Care AB
search

1. Study Identification

Unique Protocol Identification Number
NCT01214811
Brief 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
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

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Burns, Ulcers
Keywords
The change in signs of inflammation/local infection, To evaluate the comfort, conformability,, Pain during wear

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mepilex Border Ag
Arm Type
Other
Arm Description
Non comparative study with one active arm - Mepilex Border Ag
Intervention Type
Device
Intervention Name(s)
Mepilex Border Ag
Intervention Description
Mepilex Border Ag may be left in place for up to seven days, depending on the condition.
Primary Outcome Measure Information:
Title
Wound Are at Baseline
Time Frame
Baseline
Title
Wound Area at Visit 2
Description
At each visit the wound length and width is measured and calculated in cm2.
Time Frame
After one week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Latenser, MD
Organizational Affiliation
UI burn Treatment Center,200 Hawkings Dr 8JCP Iowa City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for advanced wound care
City
Momtgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Facility Name
Burn treatment center
City
Iowa city
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Center for Curative & Palliative Care, Calvary Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs