Trial Outcomes & Findings for Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene® (NCT NCT00742183)
NCT ID: NCT00742183
Last Updated: 2017-12-08
Results Overview
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
COMPLETED
NA
100 participants
August 2008-August 2009
2017-12-08
Participant Flow
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.
Participant milestones
| Measure |
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
|
Silvadene
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.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
40
|
39
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
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
|
Silvadene
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Required skin-graft
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
Baseline Characteristics
Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®
Baseline characteristics by cohort
| Measure |
Mepilex® Ag
n=49 Participants
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.
|
Silvadene® Cream 1%
n=51 Participants
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.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 18.1 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 18.2 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 18.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
51 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: August 2008-August 2009Population: 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
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
Outcome measures
| Measure |
Mepilex Ag
n=49 Participants
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).
|
Silvadene
n=51 Participants
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).
|
|---|---|---|
|
Compare the Costs of Using the Interventions (Direct and Indirect)
|
395.03 dollars
Interval 343.68 to 450.3
|
775.79 dollars
Interval 659.42 to 892.16
|
Adverse Events
Mepilex Ag
Silvadene
Serious adverse events
| Measure |
Mepilex Ag
n=49 participants at risk
Mepilex® Ag is an antimicrobial soft silicone foam dressing that absorbs exudate and maintains a moist wound environment.
|
Silvadene
n=51 participants at risk
Silvadene® Cream 1%, silver sulfadiazine is a topical antimicrobial drug.
|
|---|---|---|
|
General disorders
Death
|
2.0%
1/49 • Number of events 1
|
0.00%
0/51
|
|
General disorders
Pain
|
0.00%
0/49
|
2.0%
1/51 • Number of events 1
|
|
Investigations
Anticoagulation drug level above therapeutic
|
2.0%
1/49 • Number of events 1
|
0.00%
0/51
|
Other adverse events
| Measure |
Mepilex Ag
n=49 participants at risk
Mepilex® Ag is an antimicrobial soft silicone foam dressing that absorbs exudate and maintains a moist wound environment.
|
Silvadene
n=51 participants at risk
Silvadene® Cream 1%, silver sulfadiazine is a topical antimicrobial drug.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
10.2%
5/49 • Number of events 5
|
13.7%
7/51 • Number of events 7
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
3/49 • Number of events 3
|
7.8%
4/51 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
16.3%
8/49 • Number of events 8
|
19.6%
10/51 • Number of events 10
|
|
Infections and infestations
Staphylococcal infection
|
8.2%
4/49 • Number of events 4
|
2.0%
1/51 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.2%
6/49 • Number of events 6
|
23.5%
12/51 • Number of events 12
|
|
Surgical and medical procedures
Skin graft
|
4.1%
2/49 • Number of events 2
|
7.8%
4/51 • Number of events 4
|
|
Vascular disorders
Hypertension
|
6.1%
3/49 • Number of events 3
|
0.00%
0/51
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER