SSD vs Collagenase in Pediatric Burn Patients
Recruitment status was Active, not recruiting
The objective of this study is to evaluate the outcomes of children with burn injury with regard to the utilization of Silver sulfadiazine (SSD) cream and Collagenase ointment. The primary outcome variable will be need for skin grafting. The specific aim of the study is to prospectively collect data to determine if SSD is superior to Collagenase with regard to avoiding the need for skin grafting.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Comparison of Silver Sulfadiazine Cream and Collagenase Ointment for the Treatment of Burns in Children|
- Need for skin grafting [ Time Frame: 10 days ] [ Designated as safety issue: No ]
- Development of burn contractures [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Patients that receive SSD as the topical debriding agent
Patients that receive collagenase as the debriding agent.
During the treatment of burns, the wounds must be repeatedly debrided to remove loose and adherent dead tissue (eschar) until it is determined that the wound will require skin grafting for coverage or that the wound will re-epithelialize. The eschar associated with burn injury eventually will separate from the burn bed through proteolytic enzymes that are produced naturally in the skin or by colonizing bacteria. During this acute treatment timeframe, agents are used that can help with removal of the eschar. SSD is an antimicrobial agent that sterilizes the wound, thus preventing infection and allowing the natural proteolytic enzymes in the skin to act on the eschar leading to separation during the mechanical debridement treatment regimen. SSD was initially introduced in the 1960's and has been a mainstay of treatment for the care of burns since. It is currently used in the CMH burn unit.
Collagen is a protein that is highly present in skin (~75% of dry weight of skin), and is the dominant protein that must be divided to allow for eschar separation. Collagenase is an exogenous enzyme that breaks down native and denatured collagen. Collagenase will not however breakdown healthy, normal collagen. Collagenase is FDA approved for the treatment of burns and is now used by many burn units including the burn unit at CMH. Currently, in this institution, both SSD and collagenase are being used for the removal of eschar. Unfortunately, there has not been a properly performed prospective randomized comparison of these two regimens in children, despite the widespread use of both regimens. Because of the uncertain data regarding these approaches, as well as the fact that we currently perform both approaches here, we feel that there is equipoise in regard to the techniques. We plan to perform a prospective randomized trial comparing SSD and Collagenase in children that sustain burns and are admitted to CMH for debridement of their burns. We have reviewed our historical experience using collagenase and SSD. Utilizing the need for skin graft rates from this historical population, a sample size of 75 patients in each arm has been calculated. This sample size calculation was performed using a standard alpha and beta of 0.05 and 0.8, respectively, and assumes a 10% attrition rate. The primary endpoint for this study will be the need for skin grafting in children that sustain a burn of sufficient depth to require admission and debridement of eschar.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787592
|United States, Missouri|
|Children's Mercy Hospital and Clinics|
|Kansas City, Missouri, United States, 64108|
|Principal Investigator:||Daniel J Ostlie, MD||Children's Mercy Hospital and Clinics|