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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
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
Subject evaluation of
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex Border Ag | Experimental | Mepilex Border Ag, a silver dressing will be used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Border Ag | Device | a silver dressing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice | burns healed | 3 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fredrik Huss, MD | Akademiska Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Briva/Hpk | Linköping | Sweden | ||||
| Plastikkirurgiska kliniken, UAS BRIVA |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepilex Border Ag | Mepilex Border Ag, a silver dressing |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
small partial thickness burns
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex Border Ag | Mepilex Border Ag, ( a silver dressing) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate the Experience of Using Mepilex Border Ag ( a Silver Dressing) in Normal Clinical Practice | burns healed | small thickness partial burns | Posted | Number | burns healed | 3 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mepilex Border Ag | Mepilex Border Ag |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Swelling of left hand | General disorders | Swelling of left hand |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fredrik Huss | Uppsala Akademiska Hospital, Dept. of Plastic Surgery | +46 771 405 405 | Fredrik.Huss@surgsci.uu.se |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 3 weeks |
| Uppsala |
| Sweden |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Evaluate the Comfort | Comfort level and overall experience were each assessed using a scale that ranged from very poor to very good. | Posted | Number | participants | 3 weeks |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | units on a scale | 3 weeks |
|
|
|
| 0 |
| 15 |
| 2 |
| 15 |
| Infection left arm, no study burn | Infections and infestations | Infection left arm, no study burn |
|
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