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

NCT ID: NCT01926392

Last Updated: 2013-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Burn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

water-soluble therapy

Intervention Type 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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

water-soluble therapy

Intervention Type 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

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult inpatients with partial thickness burns

Exclusion Criteria

* superficial or full thickness burns, facial burns, intubated or sedated, pediatric
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan Black, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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15603

Identifier Type: -

Identifier Source: org_study_id