SKILLMAN, N.J., May 15 /PRNewswire/ -- A protocol of care using AQUACEL(R) Ag Hydrofiber(R) dressing demonstrated greater clinical and economic benefits in the management of adult and pediatric patients with partial thickness burns compared to a protocol of care including silver sulfadiazine (silvadene) cream, according to a study published in the current issue of Journal of Burn Care & Research. AQUACEL(R) Ag Hydrofiber(R), developed by ConvaTec, a Bristol-Myers Squibb Company, is an absorbent, antimicrobial barrier dressing containing ionic silver.
The multi-center, prospective, randomized phase III study found that AQUACEL(R) Ag Hydrofiber(R) was associated with fewer dressing changes, less nursing time and fewer procedural medications compared with silver sulfadiazine for the management of partial thickness burns. These factors contributed to lower total treatment costs in the AQUACEL(R) Ag Hydrofiber(R) group, resulting in an average cost savings of nearly $560 per burn healed.(1) Safety profiles were comparable between the two treatment groups.
“Partial thickness, or second degree, burns are the most common type of burn seen by clinicians worldwide,” said lead investigator Daniel M. Caruso, MD, FACS, Chairman of the Department of Surgery and Medical Director of The Arizona Burn Center at Maricopa Medical Center in Phoenix, AZ. “This trial, one of the first comparative studies to evaluate an advanced silver dressing against the most commonly-used topical burn treatment, shows that when all resources are considered, a protocol using AQUACEL(R) Ag is less expensive and offers a higher standard of patient care. The implications of our study are relevant for a range of healthcare professionals, as most partial thickness burns are not treated by burn specialists, but rather by general and emergency medicine practitioners,” adds Caruso.
About the Study
The phase III clinical trial evaluated protocols of care comparing AQUACEL(R) Ag Hydrofiber(R) dressing with silver sulfadiazine in 84 adult and pediatric patients with partial thickness burns for up to 21 days.(1) All patients had superficial, mid-dermal, or mixed partial thickness-burns, covering five to 40 percent of total body surface area. The primary objective of the study was to compare the cost effectiveness of the two protocols, calculated by dividing the mean total cost of care by the percentage of patients achieving full reepithelialization within the study period of 21 days.
Results showed that based on dressings, labor, and procedural medications, the mean total cost of clinical care in the AQUACEL(R) Ag Hydrofiber(R) protocol dressing group tended to be lower than silver sulfadiazine protocol group ($1,040.00 vs. $1,180.80). Furthermore, a higher percentage of patients in the AQUACEL(R) Ag dressing protocol group (73.8 percent vs. 60 percent) achieved full reepithelialization over the burn site by 21 days, resulting in an average total cost saving of nearly $560 per burn healed.
Additional secondary endpoints observed in the AQUACEL(R) Ag Hydrofiber(R) dressing group compared to the silver sulfadiazine group included:
* Fewer than half the number of dressing changes per day (.5 vs. 1.2) and in total over 21 days (7.7 vs. 19.1) * Less nursing time required per dressing change (35 minutes vs. 53 minutes) * Reduction in procedural medications required (1) * Less burning or stinging during wear (as reported by patients)(1) * Better achievement of normal scar height by the end of the study treatment (80 vs. 57 percent of patients) This phase III study was supported by a grant from ConvaTec. About ConvaTec
ConvaTec, a world-leading manufacturer of ostomy and wound care products, is at the forefront of the movement to change the way health care professionals are managing chronic and acute wounds. Since the introduction of DuoDERM(R) Hydroactive Dressing in 1982, ConvaTec has been a pioneer in the establishment of moist wound healing. Today, ConvaTec is building on this strong heritage with AQUACEL(R) Hydrofiber(R) dressing, an absorbent, soft, conformable, antimicrobial barrier dressing, that forms a cool gelling sheet on contact with exudate (wound fluid), and with newer brands such as Versiva(R) -- a sterile dressing that combines several advanced technologies to support management of exuding wounds. With a heritage of caring about patients, ConvaTec is a Bristol-Myers Squibb Company . Bristol-Myers Squibb is a global pharmaceutical and related health care products company. For more information, please call 800-422-8811 or visit http://www.convatec.com .
(1) Caruso D, et al. Randomized Clinical Study of Hydrofiber Dressing With Silver or Silver Sulfadiazine in the Management of Partial Thickness Burns; Data accepted for publication in the Journal of Burn Care Research. May-June 2006.
Contact: Ian Leggat Weber Shandwick Phone: 212-445-8265 E-mail: ileggat@webershandwick.com Pete Paradossi Bristol-Myers Squibb Phone: 812-429-7413 E-mail: pete.paradossi@bms.com
ConvaTec
CONTACT: Ian Leggat of Weber Shandwick, +1-212-445-8265,ileggat@webershandwick.com; or Pete Paradossi of Bristol-Myers Squibb,+1-812-429-7413, pete.paradossi@bms.com, both for ConvaTec
Web site: http://www.convatec.com/
