SSD vs Collagenase in Pediatric Burn Patients
Condition: Burns
MeSH terms: Burns
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children between the ages of 2 months and 18 years of age that have at least second degree
        burns that involve less than 25% of their total body surface area.
      
Keywords: Burns; children; collagenase; silver sulfadiazine; Childhood burns