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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01926392
Other study ID # 15603
Secondary ID
Status Completed
Phase Phase 4
First received August 17, 2013
Last updated August 20, 2013
Start date April 2011
Est. completion date October 2011

Study information

Verified date August 2013
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- adult inpatients with partial thickness burns

Exclusion Criteria:

- superficial or full thickness burns, facial burns, intubated or sedated, pediatric

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
United States University of Virginia Health System Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other narcotic medication administered All narcotics given for premedication and during the dressing change will be converted to their morphine-equivalent and totaled 180 minutes No
Primary 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 No
Secondary time to perform dressing changes The time to perform the dressing change in total and for various steps is recorded in minutes. up to 180 minutes No
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