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An Open, Parallel, Randomized, Comparative, Multicenter Study to Evaluate the Cost-Effectiveness, Performance, Tolerance, and Safety of a Silver-Containing Soft Silicone Foam Dressing (Intervention) vs Silver Sulfadiazine Cream.
MedLine Citation:
PMID:  21979855     Owner:  NLM     Status:  Publisher    
An open, parallel, randomized, comparative, multicenter study was implemented to evaluate the cost-effectiveness, performance, tolerance, and safety of a silver-containing soft silicone foam dressing (Mepilex Ag) vs silver sulfadiazine cream (control) in the treatment of partial-thickness thermal burns. Individuals aged 5 years and older with partial-thickness thermal burns (2.5-20% BSA) were randomized into two groups and treated with the trial products for 21 days or until healed, whichever occurred first. Data were obtained and analyzed on cost (direct and indirect), healing rates, pain, comfort, ease of product use, and adverse events. A total of 101 subjects were recruited. There were no significant differences in burn area profiles within the groups. The cost of dressing-related analgesia was lower in the intervention group (P = .03) as was the cost of background analgesia (P = .07). The mean total cost of treatment was $309 vs $513 in the control (P < .001). The average cost-effectiveness per treatment regime was $381 lower in the intervention product, producing an incremental cost-effectiveness ratio of $1688 in favor of the soft silicone foam dressing. Mean healing rates were 71.7 vs 60.8% at final visit, and the number of dressing changes were 2.2 vs 12.4 in the treatment and control groups, respectively. Subjects reported significantly less pain at application (P = .02) and during wear (P = .048) of the Mepilex Ag dressing in the acute stages of wound healing. Clinicians reported the intervention dressing was significantly easier to use (P = .03) and flexible (P = .04). Both treatments were well tolerated; however, the total incidence of adverse events was higher in the control group. The silver-containing soft silicone foam dressing was as effective in the treatment of patients as the standard care (silver sulfadiazine). In addition, the group of patients treated with the soft silicone foam dressing demonstrated decreased pain and lower costs associated with treatment.
Paul Silverstein; David Heimbach; Herbert Meites; Barbara Latenser; David Mozingo; Fred Mullins; Warren Garner; Joseph Turkowski; Jeffrey Shupp; Paul Glat; Gary Purdue
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-10-5
Journal Detail:
Title:  Journal of burn care & research : official publication of the American Burn Association     Volume:  -     ISSN:  1559-0488     ISO Abbreviation:  -     Publication Date:  2011 Oct 
Date Detail:
Created Date:  2011-10-7     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101262774     Medline TA:  J Burn Care Res     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
From the *Paul Silverstein Burn Center, Oklahoma City, Oklahoma; †Harborview Medical Center, Seattle, Washington, DC; ‡UI Burn Treatment Center, Iowa City, Iowa; §Shands Burn Center, Gainesville, Florida; ∥Joseph M. Still Research Foundation, Augusta, Georgia; ¶University of Southern California Regional Burns Center, Los Angeles; #NewYork Presbyterian/Weill Cornell Medical Center Burn Center; **The Burn Center, Washington Hospital Center; ††St Christopher's Hospital for Children, Pediatric Burn Center, Philadelphia, Pennsylvania; and ‡‡Southwestern Regional Burn Center, Dallas, Texas.
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