Rationale and Purpose Despite advantages of modern dressings, silver sulfadiazine 1% cream remains the accepted standard for protecting burn wounds from infecting organisms. This study compared healing, pain, and burn-care-related resource use for patients with partial-thickness burns managed topically with either a dressing comprised of Hydrofiber® technology with silver (HS)* or silver sulfadiazine 1% cream (SSD)**. Methods and Materials This Phase III, prospective randomized multi-center study was conducted in eight US burn centers. In-patients or out-patients with partial-thickness burns cleaned and debrided according to facility protocol, were stratified by age and total body surface area, then randomly assigned to management for up to 21 days with a regimen including topical dressings with either SSD or HS. SSD cream containing 10 mg of micronized silver sulfadiazine per gram was applied per package insert instructions once to twice daily at a thickness of 1/16 inch and covered with a discretionary outer dressing. Home SSD dressing changes were permitted between clinic visits which occurred every 2-3 days. HS dressings were applied overlapping surrounding intact skin 4-5 cm and changed in the hospital or clinic after 24 hours, then every 2-3 days at the clinician's discretion. The HS dressing, comprised of sodium carboxymethyl-cellulose and 1.2% ionic silver, sustains antimicrobial activity in the dressing and at the wound interface. It may remain in place on burns for up to 14-days at the clinician's discretion. Pain at dressing changes was observer-rated for patients aged 0-3 years and patient-reported using the Johns-Hopkins visual analog scale for patients > 4 years old. Pain and anti-anxiety medications related to burn procedures were recorded. Healing was clinically reported as percent of patients re-epithelized by 21 days and as days to fully re-epithelize. Resource utilization included costs of burn dressings, labor and burn-related medications recorded during the study. Cost effectiveness was calculated as mean total cost for the SSD or HS group divided by the % of patients re-epithelized in the same group. Experience HS and SSD patient and burn characteristics were comparable on enrollment. Of the 42 HS-dressed patients, 73.8% healed in 21 days with a mean healing time of 15.9 days. Of the 40 SSD-dressed patients 60.0% healed in 21 days (p=0.24) with a mean healing time of 16 days (p=0.52). Patients managed with HS reported significantly less pain (p=0.002) and anxiety (p=0.009) during dressing changes, with fewer episodes of procedural and opiate medication required (P=0.02). SSD dressings were associated with greater flexibility (0.002) and ease of movement (p=0.03). HS dressings were changed less frequently than SSD dressings (p<0.001) with fewer dressing changes per patient on study (p<0.001). Mean dressing change duration was 28.2 minutes in the HS group and 45.6 minutes in the SSD group (p=0.002). HS dressings required less nursing time per dressing change (p<0.001) and lower costs of nursing care than the SSD group (p<0.001), with a net savings of $559 per burn patient healed. Safety results including infection incidence were similar for both groups. Conclusion A regimen of partial-thickness burn care using HS achieved healing and safety outcomes similar to that using SSD, while reducing patient pain and anxiety and medications required for dressing changes. HS required fewer dressing changes, each consuming less nursing time than with SSD and cost $559 less for each burn healed. Based on these results a protocol of care using HS is an effective solution for managing partial-thickness burns. Product Notations * Silvadene® Cream 1%, King Pharmaceuticals, Bristol, TN **AQUACEL® Ag silver dressing with Hydrofiber® technology, ConvaTec, a Bristol-Myers Squibb company. AQUACEL and Hydrofiber are registered trademarks of E. R. Squibb & Sons, L. L. C. ©2005 E.R. Squibb & Sons, L.L.C.
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