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

Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926392
• Other study ID #: 15603
• 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

• Burn
• Burns

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