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Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01418482
First Posted: August 17, 2011
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Molnlycke Health Care AB
  Purpose
The investigation is designed as an open, non-controlled, post-marketing investigation. Subjects with at least one second degree burn less than 9.5x15 cm in size at 1-3 sites will be included. The subject is allowed to have more than one burn on the body but only one should be included in the investigation. Each subject will be followed/assessed according to normal hospital routine 1-3 times per week for a maximum of 3 weeks or until desired treatment effect is obtained if that occurs earlier. All dressing changes will be done according to clinical routine and will follow the IFU (instruction for use). All dressing changes will be registered in a dressing log. Additional compression bandaging, gauze wrap, or such are allowed and should be reported as well

Condition Intervention
Burns Device: Mepilex Border Ag

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Non-controlled Post-marketing Investigation Evaluating the Experience of Using a Self- Adherent Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns

Resource links provided by NLM:


Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice [ Time Frame: 3 weeks ]
    burns healed


Secondary Outcome Measures:
  • Evaluate the Comfort [ Time Frame: 3 weeks ]
    Comfort level and overall experience were each assessed using a scale that ranged from very poor to very good.

  • Pain [ Time Frame: 3 weeks ]
    To evaluate pain during dressing removal at visit 4,(after one week) with John Hopkins pain scale. Measured 0=no pain, 100= worst pain, scale from 0-100 mm


Enrollment: 15
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mepilex Border Ag
Mepilex Border Ag, a silver dressing will be used
Device: Mepilex Border Ag
a silver dressing

Detailed Description:

At baseline, subject characteristics will be registered together with subject status of health and status of the burn, and current treatment of the burn.

At each visit the following variables will be collected where applicable:

  • Investigator's/Nurse evaluation of

    • Overall experience of the dressing
    • Ability of dressing to stay in place (not at baseline)
    • Conformability of the dressing
    • Handling at application
    • Ease of removal of the dressing (not at baseline)
  • Subject evaluation of

    • Overall experience of the dressing
    • Comfort of the dressing
    • Conformability of the dressing
  • Pain before, during and after removal of dressing according to VAS
  • Status of skin
  • Burn status: width x length, exudate details and signs of inflammation/infection

In addition the following variables should be evaluated at each visit:

  • Concomitant medication/treatment
  • Adverse Event/Adverse Device Effect (AE/ADE)
  • Serious Adverse Event/Serious Adverse Device Effect (sAE/sADE)

Photos will be taken before Mepilex Border Ag is removed, after removal, before cleansing, and after cleansing. All photos must include a sticker marker with subject code, visit number and date, and an indication of whether pre-/post removal, pre-/post cleansing. The stick marker also contains a ruler. Detailed instructions on how to take the photos is given in Appendix 14.2

At each visit the subject will give the assessment concerning the comfort and stay-on-ability of the dressing. The investigator will also give an assessment at each visit concerning handling, conformability and ability of dressing to stay in place.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject with a small partial thickness burn (< 9.5x15 cm) where an antimicrobial action is indicated as judged by the investigator*
  2. Male or female, 18 years and above, both in- and out-patient subjects
  3. Signed Informed Consent Form

Exclusion Criteria:

  1. Wound size equal to or above 9.5x15cm for the selected burn for the investigation
  2. Pregnant and/or breastfeeding women
  3. Subject not expected to follow the investigation procedures or applicable for investigation according to the judgment of the investigator
  4. Subjects with known sensitivity to silver or any other contents of the dressing
  5. Subjects previously included in this investigation
  6. Subjects included in other ongoing clinical investigation at present or during the past 30 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418482


Locations
Sweden
Briva/Hpk
Linköping, Sweden
Plastikkirurgiska kliniken, UAS BRIVA
Uppsala, Sweden
Sponsors and Collaborators
Molnlycke Health Care AB
Investigators
Principal Investigator: Fredrik Huss, MD Akademiska Hospital
  More Information

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01418482     History of Changes
Other Study ID Numbers: MxB Ag 02
First Submitted: January 27, 2011
First Posted: August 17, 2011
Results First Submitted: April 7, 2016
Results First Posted: May 3, 2017
Last Update Posted: June 5, 2017
Last Verified: August 2011

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Anti-Infective Agents
Anti-Bacterial Agents