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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926392

Enrollment

Registered

2013-08-20

Start date

2011-04-30

Completion date

2011-10-31

Last updated

2013-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn

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.

Interventions

DRUGwater-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

DRUGsilver 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* adult inpatients with partial thickness burns

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026