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Completed Prospective Studies A Prospective Comparison of Silver Sulfadiazine Cream and Collagenase Ointment for the Treatment of Burns

Ostlie, Daniel J.; Juang, David; Aguayo, Pablo; Pettiford-Cunningham, Janine P.; Erkmann, Erin A.; Rash, Diane E.; Sharp, Susan W.; Sharp, Ronald, J.; St. Peter, Shawn D. "Topical Silver Sulfadiazine vs. Collagenase Ointment for the Treatment of Partial Thickness Burns in Children: A Prospective Randomized Trial." Journal of Pediatric Surgery. 47, (2012): 1204-1207.

This is a single center, prospective randomized clinical trial comparing two treatment regimens for the management of partial thickness burns for patients admitted to the Children's Mercy Burn Unit.

There are two study groups. Group One is composed of patients undergoing treatment with collagenase ointment and polymyxin powder. Group Two consists of patients undergoing treatment with SSD cream. 

All patients are admitted to the burn unit and undergo standard burn resuscitation using the Parkland formula. The burns will be debrided on admission in the standard fashion followed by 48 hours of SSD treatment to sterilize the burn bed.

Parents/guardians of the patients are informed of the study and permission/assent for randomization is obtained prior to initiating one of the two treatment regimens. In patients that are enrolled in the study, after 48 hours of SSD treatment, the randomization to either continue SSD or change to collagenase/polymyxin is determined.

Following randomization, all patients undergo once-daily treatments with either SSD or collagenase/polymyxin. Treatment continues for ten days or until the wound has re-epithelialized. If the burn wound is not re-epithelialized after ten days, a decision for grafting will be made by one of the burn surgeons. 

Randomization is determined using a computer-generated randomization sequence that is non-stratified and blocked in groups of ten.

A power analysis using retrospective skin graft rates at our hospital for patients receiving collagenase and SSD treatment protocols with an alpha of 0.05 and a power of 0.80 yielded a sample size of 67 patients in each arm. Assuming a 10% attrition rate, we plan on enrolling about 75 patients in each arm.

Patient data collected includes age; weight; height; gender; birth order; home zip code; mechanism of injury; location(s) of burn; percent of total body surface area (TBSA) burned; percent of TBSA partial thickness burn; NPO duration; need for skin grafting; type of skin graft performed; TBSA percent that underwent skin grafting; location of skin graft; number of days post-burn that skin grafting occurred; number of days post-burn that burn wound re-epithelialized; infectious complications; operative approach(s); operative time(s); hospital charges; length of follow-up; and complications.

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