Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns
Primary Purpose
Burn
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
water-soluble therapy
silver sulfadiazine
Sponsored by
About this trial
This is an interventional treatment trial for Burn
Eligibility Criteria
Inclusion Criteria:
- adult inpatients with partial thickness burns
Exclusion Criteria:
- superficial or full thickness burns, facial burns, intubated or sedated, pediatric
Sites / Locations
- University of Virginia Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
water-soluble therapy
silver sulfadiazine
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
time to perform dressing changes
The time to perform the dressing change in total and for various steps is recorded in minutes.
Full Information
NCT ID
NCT01926392
First Posted
August 17, 2013
Last Updated
August 20, 2013
Sponsor
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT01926392
Brief Title
Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns
Official Title
A Prospective Randomized Trial Comparing Silver Sulfadiazine Cream to a Water-Soluble Poly-Antimicrobial Gel in Partial Thickness Burn Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
water-soluble therapy
Arm Type
Experimental
Arm Description
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
Arm Title
silver sulfadiazine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
water-soluble therapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
silver sulfadiazine
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain level
Description
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
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
time to perform dressing changes
Description
The time to perform the dressing change in total and for various steps is recorded in minutes.
Time Frame
up to 180 minutes
Other Pre-specified Outcome Measures:
Title
narcotic medication administered
Description
All narcotics given for premedication and during the dressing change will be converted to their morphine-equivalent and totaled
Time Frame
180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult inpatients with partial thickness burns
Exclusion Criteria:
superficial or full thickness burns, facial burns, intubated or sedated, pediatric
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Black, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns
We'll reach out to this number within 24 hrs