N/A
N=15
Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns
Burns
Bottom Line
View on ClinicalTrials.gov: NCT01418482 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice — 9 burns healed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mepilex Border Ag (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice |
9 | — |
| SECONDARY Evaluate the Comfort |
15; 14 | — |
| SECONDARY Pain |
— | — |
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
Eligibility Criteria
Inclusion Criteria
- Subject with a small partial thickness burn (< 9.5x15 cm) where an antimicrobial action is indicated as judged by the investigator*
- Male or female, 18 years and above, both in- and out-patient subjects
- Signed Informed Consent Form
Exclusion Criteria
- Wound size equal to or above 9.5x15cm for the selected burn for the investigation
- Pregnant and/or breastfeeding women
- Subject not expected to follow the investigation procedures or applicable for investigation according to the judgment of the investigator
- Subjects with known sensitivity to silver or any other contents of the dressing
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Data sourced from ClinicalTrials.gov (NCT01418482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.