SSD vs Collagenase in Pediatric Burn Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Children's Mercy Hospital Kansas City.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00787592
First received: November 6, 2008
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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.


Condition
Burns

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • Need for skin grafting [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Development of burn contractures [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 100
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)
Groups/Cohorts
1

SSD:

Patients that receive SSD as the topical debriding agent

2

Collagenase:

Patients that receive collagenase as the debriding agent.


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.

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  1. Partial thickness burn
  2. Less than 25% total body surface area burn
  3. Less than 18 years of age
  4. Greater than 2 months of age

Exclusion Criteria:

  1. Greater than 25% total body surface burn
  2. 18 years of age or older
  3. Younger than 2 months of age
  4. Allergy to sulfa
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787592

Locations
United States, Missouri
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Daniel J Ostlie, MD Children's Mercy Hospital and Clinics
  More Information

Publications:
Responsible Party: Daniel J Ostlie, MD, Children's Mercy Hospital and Clinics
ClinicalTrials.gov Identifier: NCT00787592     History of Changes
Other Study ID Numbers: 07-11-174
Study First Received: November 6, 2008
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
Burns
children
collagenase
silver sulfadiazine
Childhood burns

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Silver Sulfadiazine
Sulfadiazine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats

ClinicalTrials.gov processed this record on July 26, 2014