NCT00742183

Evaluating the Cost-effectiveness, Efficacy, Safety and Tolerance of Mepilex® Ag Versus Silvadene®

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Second Degree Burn

Interventions

Type	Name	Description
DEVICE	Mepilex	Mepilex Ag - dressing changes every 5-7 days, more frequently if needed
DEVICE	Silvadene	Silvadene - dressing changes every day, more frequently if needed

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-10-01
• Completion: 2009-11-01
• First posted: 2008-08-27
• Last updated: 2017-12-08
• Results posted: 2010-11-19

Locations

10 sites across 1 country: United States