Evaluation of Antimicrobial Soft Silicone, Silver Containing, Foam Dressing, Mepilex Border Ag, in Second Degree Burns
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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 |
- 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).
- 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) |
-
Device: Mepilex Border Ag
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 |
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
Contacts and Locations| Sweden | |
| Briva/Hpk | |
| Linköping, Sweden | |
| Plastikkirurgiska kliniken, UAS BRIVA | |
| Uppsala, Sweden | |
| 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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013