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

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

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.

Study Overview

• Status: Completed
• Conditions: Burn
• Intervention / Treatment: Drug: water-soluble therapy; Drug: silver sulfadiazine

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult inpatients with partial thickness burns

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
narcotic medication administered	All narcotics given for premedication and during the dressing change will be converted to their morphine-equivalent and totaled	180 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): October 1, 2011

Study Registration Dates

• First Submitted: August 17, 2013
• First Submitted That Met QC Criteria: August 17, 2013
• First Posted (ESTIMATE): August 20, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 21, 2013
• Last Update Submitted That Met QC Criteria: August 20, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Coccidiostats; Sulfadiazine; Silver Sulfadiazine
• Other Study ID Numbers: 15603