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Completed

NCT Number: NCT01926392

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

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.

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Key information

Conditions

Burn Burns Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult inpatients with partial thickness burns

Exclusion criteria

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

Treatment and study plan

water-soluble therapy

Drug

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

Drug

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 outcomes

  1. Pain level

    Time frame: 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 outcomes

  1. time to perform dressing changes

    Time frame: up to 180 minutes

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

Other outcomes

  1. narcotic medication administered

    Time frame: 180 minutes

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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

A Prospective Randomized Trial Comparing Silver Sulfadiazine Cream to a Water-Soluble Poly-Antimicrobial Gel in Partial Thickness Burn Wounds

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 20, 2013
Registry last updated
Aug 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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