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

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

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

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Device: Mepilex Border Ag

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden
    • Briva/Hpk
  • Uppsala, Sweden
    • Plastikkirurgiska kliniken, UAS BRIVA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mepilex Border Ag; Mepilex Border Ag, a silver dressing will be used	Device: Mepilex Border Ag; a silver dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice	burns healed	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the Comfort	Comfort level and overall experience were each assessed using a scale that ranged from very poor to very good.	3 weeks
Pain	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	3 weeks

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Fredrik Huss, MD, Akademiska hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: August 16, 2011
• First Posted (Estimate): August 17, 2011

Study Record Updates

• Last Update Posted (Actual): June 5, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: MxB Ag 02