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

Phase 4

Completed

• Conditions: Burn
• Interventions: Drug: water-soluble therapy; Drug: silver sulfadiazine

• Registration Number: NCT01926392
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-08
• Study First Submitted: 2013-08-17
• Study First Submitted QC: 2013-08-17
• Study First Posted: 2013-08-20
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• adult inpatients with partial thickness burns

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
water-soluble therapy	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
water-soluble therapy	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
silver sulfadiazine	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	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States