title: 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.
abstract: 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.
authors: Paul Silverstein Burn Center, Oklahoma City, Oklahoma 73116, USA.
authors: Paul
authors: P
authors: Silverstein
authors: David
authors: D
authors: Heimbach
authors: Herbert
authors: H
authors: Meites
authors: Barbara
authors: B
authors: Latenser
authors: David
authors: D
authors: Mozingo
authors: Fred
authors: F
authors: Mullins
authors: Warren
authors: W
authors: Garner
authors: Joseph
authors: J
authors: Turkowski
authors: Jeffrey
authors: J
authors: Shupp
authors: Paul
authors: P
authors: Glat
authors: Gary
authors: G
authors: Purdue
mesh_terms: D000328:Adult; D000891:Anti-Infective Agents, Local / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D001458:Bandages / Q000191:economics*; D002056:Burns / Q000150:complications* / Q000191:economics; D003362:Cost-Benefit Analysis; D005260:Female; D017048:Health Care Costs; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D009825:Oklahoma; D010146:Pain / Q000188:drug therapy; D010147:Pain Measurement; D012828:Silicones / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D018030:Silver Compounds / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D012837:Silver Sulfadiazine / Q000009:adverse effects / Q000191:economics* / Q000627:therapeutic use; D013223:Statistics as Topic; D014945:Wound Healing / Q000187:drug effects* / Q000502:physiology
chemical_list: D000891:Anti-Infective Agents, Local; D012828:Silicones; D018030:Silver Compounds; D012837:Silver Sulfadiazine