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

Study Overview
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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.

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

Conditions
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Burn

Intervention / Treatment
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* Drug: water-soluble therapy
* Drug: silver sulfadiazine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: water-soluble therapy<br>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<br>* 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<br>Drug: silver sulfadiazine<br>* 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<br>|
| Active Comparator: silver sulfadiazine<br>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<br>* 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<br>Drug: silver sulfadiazine<br>* 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<br>|

What is the study measuring?
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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 |