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.

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.

Randomized clinical study of Hydrofiber dressing with silver or silver sulfadiazine in the management of partial-thickness burns.

This prospective, randomized study compared protocols of care using either AQUACEL Ag Hydrofiber (ConvaTec, a Bristol-Myers Squibb company, Skillman, NJ) dressing with silver (n = 42) or silver sulfadiazine (n = 42) for up to 21 days in the management of partial-thickness burns covering 5% to 40% body surface area (BSA). AQUACEL Ag dressing was associated with less pain and anxiety during dressing changes, less burning and stinging during wear, fewer dressing changes, less nursing time, and fewer procedural medications. Silver sulfadiazine was associated with greater flexibility and ease of movement. Adverse events, including infection, were comparable between treatment groups. The AQUACEL Ag dressing protocol tended to have lower total treatment costs (Dollars 1040 vs. Dollars 1180) and a greater rate of re-epithelialization (73.8% vs 60.0%), resulting in cost-effectiveness per burn healed of Dollars 1,409.06 for AQUACEL Ag dressing and Dollars 1,967.95 for silver sulfadiazine. A protocol of care with AQUACEL(R) Ag provided clinical and economic benefits compared with silver sulfadiazine in patients with partial-thickness burns.

The use of a collagen sponge/living cell composite material to treat donor sites in burn patients.

The objective of this study was to examine the safety and efficacy of bilayered cellular matrix, (OrCel) Ortec International, Inc., New York, NY in facilitating timely wound closure of split-thickness donor sites in severely burned patients. We utilized a matched pairs design; each patient had two designated donor sites of equivalent surface area and depth. Sites were randomized to receive a single treatment of either OrCel or the standard dressing Biobrane-L (Bertek Pharmaceuticals) Sugarland, TX. The results demonstrate that OrCel was more effective in facilitating timely wound closure of split-thickness skin donor sites than Biobrane-L. The healing time for OrCel sites was significantly shorter than for sites treated with Biobrane-L. This acceleration of wound healing was clinically important in enabling earlier recropping. OrCel sites also exhibited reduced scarring. Therefore, treatment of donor site wounds with OrCel is well tolerated, promotes more rapid healing, and results in reduced scarring when compared with conventional therapy with Biobrane-L.

A premature infant with skin injury successfully treated with bilayered cellular matrix.

The immature skin of premature infants is functionally less effective than the skin of full-term infants and therefore more vulnerable to injury. This article discusses the use of a biologic wound healing agent--bilayered cellular matrix--to heal a denuded hip wound in a premature infant. The treatment involved a compassionate use, single application of an investigational biologic wound healing agent to a 2.0-cm x 1.5-cm hip wound in a 23-week gestational age premature infant. A sterile, nonadherent dressing containing 3% bismuth tribromophenate in a special petrolatum blend on a fine mesh gauze also was applied over the biologic dressing and changed as needed. Wound closure was evaluated by photographs taken before and after the application of the bilayered cellular matrix. Wound measurements were reduced to 1.0 cm x 0.5 cm by day 4 post application of the bilayered cellular matrix, and clean granulation tissue was present. The wound was healed 10 days later. No signs or symptoms of infection were evident during the follow-up period and no adverse events were recorded. Comparative studies are warranted to fully evaluate the utility of bilayered cellular matrix in this clinical setting.