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Effectiveness of Cerium NitrateSilver Sulfadiazine in the Treatment of Facial Burns: A Multicenter, Randomized, Controlled Trial

Oen, Irma M. M. H. M.D.; van Baar, Margriet E. Ph.D.; Middelkoop, Esther Ph.D.; Nieuwenhuis, Marianne K. Ph.D.

Plastic & Reconstructive Surgery:
doi: 10.1097/PRS.0b013e3182589d63
Reconstructive: Head and Neck: Original Articles
Abstract

Background: The face is a very frequent site of burn injuries. This multicenter, randomized, controlled trial thus investigates the effectiveness of cerium nitrate–silver sulfadiazine in the treatment of facial burns compared with silver sulfadiazine.

Methods: Adult patients with acute facial burns admitted to Dutch burn centers were randomized to treatment with either cerium nitrate–silver sulfadiazine or silver sulfadiazine. Primary outcome was need for surgery and time to wound healing. Aesthetic and functional outcome was assessed at 3, 6, and 12 months after burn.

Results: From March of 2006 until January of 2009, 179 patients were randomized and 154 could be included. The two groups of patients (cerium nitrate–silver sulfadiazine group, n = 78; silver sulfadiazine group, n = 76), were comparable regarding sex, age, percentage total body surface area burned, and cause. During admission, four patients died, leaving 77 and 73 patients for primary analyses, respectively. Surgery was required in 13 (16.9 percent) compared with 15 patients (20.5 percent) (p = 0.57; odds ratio, 0.8; 95 percent CI, 0.3 to 1.8), respectively. Median time to wound healing was 11.0 days in the cerium nitrate–silver sulfadiazine group (interquartile range, 7.0 to 15.0) and 9.0 days for silver sulfadiazine group (interquartile range, 5.0 to 15.75) (p = 0.17). There were no significant differences in functional and aesthetic outcome.

Conclusions: No differences were found in effectiveness of both treatments. The vast majority of facial burns do not require surgery, and treatment with cerium nitrate–silver sulfadiazine and silver sulfadiazine leads to satisfactory outcome, both aesthetically and functionally.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Author Information

Rotterdam, Beverwijk, and Groningen, The Netherlands

From the Burn Centre, Maasstad Hospital, and the Association of Dutch Burn Centers of Burn Centre Maasstad Hospital, Burn Centre Red Cross Hospital, and Burn Centre Martini Hospital.

Received for publication November 7, 2011; accepted February 6, 2012.

This trial is registered under the name “Treatment of Facial Burns With Flammacerium Compared to Flammazine and the Impact of Facial Burns on Psychosocial Wellbeing,” ClinicalTrials.gov identification number NCT00297752 (http://www.clinicaltrials.gov/ct2/show/NCT00297752), registration date February 28, 2006.

Presented in part at the European Burns Association Congress, in Lausanne, Switzerland, September 2 through 5, 2009; the Spring Meeting of the Dutch Burn Care Society, in Rotterdam, The Netherlands, March 26, 2010; and the National Congress of the Société Française d'Etude et de Traitement des Brûlures, in Lyon, France, June 9 through 11, 2010.

Disclosure: The authors have no conflicts of interest to report.

Marianne K. Nieuwenhuis, Ph.D.; Association of Dutch Burn Centers, Burn Centre, Martini Hospital, P.O. Box 30.033, 9700 RM Groningen, The Netherlands, m.k.nieuwenhuis@mzh.nl

©2012American Society of Plastic Surgeons