Second Degree Burn
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMepilex
Mepilex Ag - dressing changes every 5-7 days, more frequently if needed
DEVICESilvadene
Silvadene - dressing changes every day, more frequently if needed
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a second degree burn covering 5% to 20% BSA. TBSA covered with burn is allowed to be up to 25%, allowing a maximum of 10% to be third degree burn (only the Second degree burn should be treated) * Burn of thermal origin * Both gender with an age ≥ 5 years at randomization * Signed informed consent * Subjects who are younger than the legal consenting age must have a legally authorized representative
Exclusion criteria
* \- Burns equal to or older than 36 hours * Burns of chemical and electrical origin * Clinically infected Burn (as judged by the investigator) * Treatment of the burn with an active agent before study entry, SSD is allowed up to 24 hours prior to randomization * Patients with necrotising leucocytic vasculitis or pyoderma gangrenosa. * Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment. * Patients with insulin dependent diabetes mellitus * Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolon/day or equivalent. * Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days. * Known allergy/hypersensitivity to any of the components of the investigation products. * Patients with physical and/or mental conditions that are not expected to comply with the investigation. * Participation in other clinical investigation(s) within 1 month prior to start of the investigation * Pregnancy * Previously randomised to this investigation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the Costs of Using the Interventions (Direct and Indirect) | August 2008-August 2009 | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| 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. | 51 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 3 |
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Required skin-graft | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Silvadene® Cream 1% | Mepilex® Ag | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 41 Participants | 82 Participants |
| Age, Continuous | 39.2 years STANDARD_DEVIATION 18.2 | 37.0 years STANDARD_DEVIATION 18.1 | 38.4 years STANDARD_DEVIATION 18.2 |
| Region of Enrollment United States | 51 participants | 49 participants | 100 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 23 Participants |
| Sex: Female, Male Male | 41 Participants | 36 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 49 | 26 / 51 |
| serious Total, serious adverse events | 2 / 49 | 1 / 51 |
Outcome results
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
Time frame: August 2008-August 2009
Population: 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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mepilex Ag | Compare the Costs of Using the Interventions (Direct and Indirect) | 395.03 dollars |
| Silvadene | Compare the Costs of Using the Interventions (Direct and Indirect) | 775.79 dollars |