Second Degree BurnNCT00742183
Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®
A study testing Mepilex and Silvadene in people with Second Degree Burn, run by Molnlycke Health Care AB at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Second Degree Burn
- What is being tested?
- Mepilex and Silvadene
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesUnited States
- Study dates
- Aug 2008to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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.
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Joseph Still Burn Center
Augusta, Georgia, 30909
Southwestern Regional Burn Center, Parkland Hospital
Dallas, Texas, 75235
Shands Burn Center, University of Florida
Gainesville, Florida, 32610
UI Burn Treatment center
Iowa City, Iowa, 52242
LA County Hospital & USC Medical Center
Los Angeles, California, 90033
Cornell Medical Center
New York, New York, 10065
Paul Silverstein Burn center
Oklahoma City, Oklahoma, 73112
St Christopher's Hospital
Philadelphia, Pennsylvania, 19134
Department of Surgery
Seattle, Washington, 98104
The Burn Center, Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: An Open, Parallel, Randomized, Comparative, Multi-centre Investigation in US Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene® in the Treatment of Partial Thickness Burns.
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.
Read the 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.
- Conditions
- Second Degree Burn
- Being tested
- Mepilex, Silvadene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepilexDevice
Mepilex Ag - dressing changes every 5-7 days, more frequently if needed
SilvadeneDevice
Silvadene - dressing changes every day, more frequently if needed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mepilex |
| 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. Receives: Device: Silvadene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: August 2008-August 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Second Degree BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Silverstein, Principal investigator, Paul Silverstein Burn Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742183
- Sponsor's protocol ID
- PUMA 415
- Status last verified
- Nov 2017
- First submitted
- 19 Aug 2008
- Last updated
- 8 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Parallel, Randomized, Comparative, Multi-centre Investigation in US Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene® in the Treatment of Partial Thickness Burns.
- ClinicalTrials.gov ID
- NCT00742183
- Acronym / sponsor ID
- PUMA 415
- Conditions
- Second Degree Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 27 Aug 2008 (estimated)
- Results
- Posted 19 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepilex® Ag | Experimental | Device: MepilexMepilex® 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. |
| Silvadene® Cream 1% | Active comparator | Device: SilvadeneSilvadene® 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MepilexMepilex Ag - dressing changes every 5-7 days, more frequently if needed | Device | Mepilex® Ag |
| SilvadeneSilvadene - dressing changes every day, more frequently if needed | Device | Silvadene® Cream 1% |
Primary outcome
Compare the Costs of Using the Interventions (Direct and Indirect)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Silverstein principal investigator
Paul Silverstein Burn Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepilex and Silvadene in people with Second Degree Burn, run by Molnlycke Health Care AB at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the Costs of Using the Interventions (Direct and Indirect) (time frame: August 2008-August 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.