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Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer Ag will be used as wound contact layer and gauze rolls and compression as second dressing.
Approximately 10 subjects from one site will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent.
Subjects may have sustained a burn injury covering 1-25% of the Total Body Surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial thickness in dept. Each subject will be followed one time per week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. Healing is defined as ≥95% epithelialisation. Percent (%) healed epithelialization will be measured by photo analysing using the PictZar program. Dressing changes will be performed at each visit and in between if deemed necessary by the investigator.Gauze rolls and compression will be used as secondary dressing.All dressing changes will be registered in a log. Pain before, during and after removal will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dressing | Experimental | Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex Transfer Ag | Device | A soft silicone wound contact layer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Wound Healing | Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. ("The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.") Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier. | 14 days and 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal | Pain will be measured by using the VAS scale, by placing a vertical mark across the 100 mm long horizontal line, from No pain to the left to Most intense pain imaginable to the right. Baseline (Visit 1) Pain will be measured before burn assessment Visit 2-4, Pain will be measured (Pain BEFORE dressing removal, DURING dressing removal, AFTER dressing removal, 30 min after removal |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Schweiger, MD | Florida Gulf-toBay Anesthesiology, Tampa Bay Circle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Gulf-to-bay Anesthesiology | Tampa | Florida | 33606 | United States | ||
| Long Island Plastic Surgical Group, P.C |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dressing | Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: A soft silicone wound contact layer. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| After 0/14/21 days treatment |
| Garden City |
| New York |
| 11530 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex Transfer Ag |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Number of Participants With Wound Healing | Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. ("The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.") Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier. | Posted | Number | participants | 14 days and 21 days |
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| Secondary | Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal | Pain will be measured by using the VAS scale, by placing a vertical mark across the 100 mm long horizontal line, from No pain to the left to Most intense pain imaginable to the right. Baseline (Visit 1) Pain will be measured before burn assessment Visit 2-4, Pain will be measured (Pain BEFORE dressing removal, DURING dressing removal, AFTER dressing removal, 30 min after removal | No data collected | Posted | After 0/14/21 days treatment |
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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 | Dressing | Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties. Mepilex Transfer Ag: A soft silicone wound contact layer. | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Wilson | Mölnlycke Health Care | +1 706-650-1012 | joan.wilson@molnlycke.com |