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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:
Information provided by:
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01418482
First received: January 27, 2011
Last updated: August 16, 2011
Last verified: August 2011
  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 Phase
Burns
Device: Mepilex Border Ag
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 in normal clinical practice [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    The primary objective is to evaluate the experience of using Mepilex Border Ag in normal clinical practice when used on small second degree burns (< 9.5x15 cm) in need of topical antimicrobial treatment according to the treating physician, i.e. increasing signs of infection, odour, pain and exudate (none, mild, moderate and severe).


Secondary Outcome Measures:
  • Evaluate the comfort [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Secondary objectives are to evaluate the comfort, conformability, handling at application, ability to stay in place, pain during wear (in-between dressing changes) and at removal of dressing and adverse events according to the subject and treating hospital staff. Scale used is from very poor - very good.

  • Pain [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    To evaluate pain before dressing removal,during dressing removal and after dressing removal measured with John Hopkins pain scale.


Enrollment: 14
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Mepilex Border Ag
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Viktoria Ahlenius Körner, Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01418482     History of Changes
Other Study ID Numbers: MxB Ag 02
Study First Received: January 27, 2011
Last Updated: August 16, 2011
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014