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The primary objective is to compare the incremental costs (direct and indirect) and benefits (healing outcomes, quality of life) of using foam silver dressing (Mepilex® Ag) to a Silver sulfadiazine 1% cream (Silvadene®) from the perspective of the health care provider.
The secondary objectives are to investigate the safety, the tolerance and the performance on burn status including pain.
In- and/or out-patients at ten centers in the United States were included in this investigation. Subjects included were 5 years of age and older who suffered from partial thickness burns. Every patient was followed for 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepilex® Ag | Experimental | Mepilex® Ag consists of a Safetac® soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. Mepilex® Ag is an antimicrobial soft silicone foam dressing that absorbs exudate and maintains a moist wound environment. Mepilex® Ag contains silver sulphate that releases silver ions to inactivate a wide range of wound related pathogens (bacteria and fungi), shown in vitro. By reducing the number of microorganisms, Mepilex® Ag may also reduce odour. |
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| Silvadene® Cream 1% | Active Comparator | Silvadene® Cream 1% (silver sulfadiazine) is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second-and third-degree burns. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepilex | Device | Mepilex Ag - dressing changes every 5-7 days, more frequently if needed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the Costs of Using the Interventions (Direct and Indirect) | The incremental cost-effectiveness ratio is calculated as the difference in total costs in each group divided by the difference in rate of full re-epithelialization (taken from the survival curve) at 20 days in each group (Δcosts/ Δeffects). Total costs were calculated based on the costs of primary and secondary dressings, silver sulphadiazine cream and estimated application, labor, supplies and pain medications. These costs were estimated from a representative sample of each population, across study facilities, using activity-based costing methods. The incremental cost-effectiveness ratio is interpreted as the price of additional health benefits. The ratio is supposed to be used by decision makers, in order for them to compare their willingness-to-pay for an additional health benefit with the pr | August 2008-August 2009 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Silverstein | Paul Silverstein Burn Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LA County Hospital & USC Medical Center | Los Angeles | California | 90033 | United States | ||
| The Burn Center, Washington Hospital Center |
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Investigation period: Sept 2008 - Sept 2009. In- and/or out-patients at ten centers in US were included in this investigation. Subjects included were 5 years and above and suffered from partial thickness burns.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mepilex Ag | Treatment period will be a maximum of three weeks with Silvadene® or Mepilex® Ag. Dressing changes of Mepilex® Ag will be performed every 5-7 day, depending on the status of the burn |
| FG001 | Silvadene |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Silvadene |
| Device |
Silvadene - dressing changes every day, more frequently if needed |
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| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Shands Burn Center, University of Florida | Gainesville | Florida | 32610 | United States |
| Joseph Still Burn Center | Augusta | Georgia | 30909 | United States |
| UI Burn Treatment center | Iowa City | Iowa | 52242 | United States |
| Cornell Medical Center | New York | New York | 10065 | United States |
| Paul Silverstein Burn center | Oklahoma City | Oklahoma | 73112 | United States |
| St Christopher's Hospital | Philadelphia | Pennsylvania | 19134 | United States |
| Southwestern Regional Burn Center, Parkland Hospital | Dallas | Texas | 75235 | United States |
| Department of Surgery | Seattle | Washington | 98104 | United States |
Silver sulfadiazine 1% cream treatment period will be a maximum of three weeks. Dressing changes of Silvadene® will be performed at least once per day.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mepilex® Ag | The dressing to be used Mepilex® Ag, consists of an absorbent polyurethane foam pad containing silver sulphate with a silicone contact layer with the Safetac® technology. The silver ions are hydro activated in presence of fluid or wound exudates. |
| BG001 | Silvadene® Cream 1% | Silvadene® Cream 1%, silver sulfadiazine is a topical antimicrobial drug indicated as an adjunct for the prevention and treatment of wound sepsis in patients with second-and third-degree burns. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Compare the Costs of Using the Interventions (Direct and Indirect) | The incremental cost-effectiveness ratio is calculated as the difference in total costs in each group divided by the difference in rate of full re-epithelialization (taken from the survival curve) at 20 days in each group (Δcosts/ Δeffects). Total costs were calculated based on the costs of primary and secondary dressings, silver sulphadiazine cream and estimated application, labor, supplies and pain medications. These costs were estimated from a representative sample of each population, across study facilities, using activity-based costing methods. The incremental cost-effectiveness ratio is interpreted as the price of additional health benefits. The ratio is supposed to be used by decision makers, in order for them to compare their willingness-to-pay for an additional health benefit with the pr | Primary analysis: the Intention To Treat (ITT) population will include all patients subject to at least one post-randomisation treatment and that provide some data for the primary endpoint. If there are any patients included which do not comply with the inclusion/exclusion criteria they will be included in the ITT population | Posted | Mean | 95% Confidence Interval | dollars | August 2008-August 2009 |
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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 Ag | Mepilex® Ag is an antimicrobial soft silicone foam dressing that absorbs exudate and maintains a moist wound environment. | 2 | 49 | 20 | 49 | ||
| EG001 | Silvadene | Silvadene® Cream 1%, silver sulfadiazine is a topical antimicrobial drug. | 1 | 51 | 26 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | Patient died, description of SAE was Acute Bronco spasm. The patient had a history of CHF. Relationship to investigation product judged as unlikely |
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| Pain | General disorders | Systematic Assessment |
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| Anticoagulation drug level above therapeutic | Investigations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin graft | Surgical and medical procedures | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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The Coordinating Investigator will be the lead author for the mail (primary) publication from this Investigation. For any abstract and/or manuscript the Investigators will be given at least 14 days review time before the intended submission of the document.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Viktoria Ahlenius Körner | Mölnlycke Health Care | +46-31-722 32 46 | viktoria.ahleniuskorner@molnlycke.com |
| >=65 years |
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| Male |
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