Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns
A Prospective Randomized Trial Comparing Silver Sulfadiazine Cream to a Water-Soluble Poly-Antimicrobial Gel in Partial Thickness Burn Wounds
1 other identifier
interventional
8
1 country
1
Brief Summary
Partial thickness burns are a common, painful injury requiring a great deal of resources in their care. Silver sulfadizine is a commonly-used topical antimicrobial, but is difficult to remove due to its lipid base. We are comparing a water-based topical antimicrobial therapy to silver sulfadiazine and hypothesize that the water-based therapy is superior in terms of pain control and resources required to deliver care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 17, 2013
CompletedFirst Posted
Study publicly available on registry
August 20, 2013
CompletedAugust 21, 2013
August 1, 2013
6 months
August 17, 2013
August 20, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Pain level
Pain is assessed on a 0-10 point scale using both the patient's reported value and correlating with the value derived from nursing assessment using the visual analog scale. This is recorded at defined time points before, during, and after the dressing change
180 minutes
Secondary Outcomes (1)
time to perform dressing changes
up to 180 minutes
Other Outcomes (1)
narcotic medication administered
180 minutes
Study Arms (2)
water-soluble therapy
EXPERIMENTALThe patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis
silver sulfadiazine
ACTIVE COMPARATORThe patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis
Interventions
The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis
The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis
Eligibility Criteria
You may qualify if:
- adult inpatients with partial thickness burns
You may not qualify if:
- superficial or full thickness burns, facial burns, intubated or sedated, pediatric
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Black, MD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2013
First Posted
August 20, 2013
Study Start
April 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
August 21, 2013
Record last verified: 2013-08