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

Burns Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

• Burns

• NCT number: NCT01418482
• Study type: Interventional
• Source: Molnlycke Health Care AB
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2011
• Completion date: July 2011