Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT01926392
Collaborator
(none)
8
1
2
6
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: water-soluble therapy
  • Drug: silver sulfadiazine
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Trial Comparing Silver Sulfadiazine Cream to a Water-Soluble Poly-Antimicrobial Gel in Partial Thickness Burn Wounds
Study Start Date :
Apr 1, 2011
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: water-soluble therapy

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

Drug: water-soluble therapy
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

Drug: silver sulfadiazine
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

Active Comparator: silver sulfadiazine

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

Drug: water-soluble therapy
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

Drug: silver sulfadiazine
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

Outcome Measures

Primary Outcome Measures

  1. Pain level [180 minutes]

    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

  1. time to perform dressing changes [up to 180 minutes]

    The time to perform the dressing change in total and for various steps is recorded in minutes.

Other Outcome Measures

  1. narcotic medication administered [180 minutes]

    All narcotics given for premedication and during the dressing change will be converted to their morphine-equivalent and totaled

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • adult inpatients with partial thickness burns
Exclusion Criteria:
  • superficial or full thickness burns, facial burns, intubated or sedated, pediatric

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Virginia Health System Charlottesville Virginia United States 22908

Sponsors and Collaborators

  • University of Virginia

Investigators

  • Principal Investigator: Jonathan Black, MD, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01926392
Other Study ID Numbers:
  • 15603
First Posted:
Aug 20, 2013
Last Update Posted:
Aug 21, 2013
Last Verified:
Aug 1, 2013
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2013