NCT02108535

Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Sorocaba · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The evidence is insufficient to determine whether the types of dressings containing silver differ in time / proportion for complete wound healing and pain. We will analyze the cost-effectiveness of these dressings in outpatients, considering the service provided by the Brazilian National Public Health System.

Detailed description

Randomized, single-center, single-blinded, controlled clinical trial. Adult patients (age between 18 and 65 years), regardless of sex, with second degree burns treated in outpatient regimen will be randomized (1:1) into two groups: 1% silver sulfadiazine and nanocrystalline silver. Primary outcome: \- Proportion of lesions completely epithelialized within 15 days. Secondary outcomes: * Time in days for complete epithelialization of the burned areas; * Number of dressing changes; * Level of pain associated with the application and removal of the dressings; * Direct medical and non-medical costs; * Need for surgery; * Incidence of infection; * Presence of local adverse reactions.

Conditions

• Second-degree Burn

Interventions

Type	Name	Description
DRUG	Nanocrystalline silver	Flexible polyester low-grip coated nano-crystalline silver layer. The level of silver is 1.64 mg/ cm². This dressing enables the sustained release of silver in humid conditions dynamically and reached a higher plateau than 60 mg / L in less than 2 hours, and maintains a uniform level by 72 hours.
DRUG	Silver Sulfadiazine	This is at Standard treatment. The cream silver sulphadiazine at 1% was applied on the burn aseptically in a thick layer, approximately 3 to 5 mm, ie 5 g per 80 cm2

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-08-01
• Completion: 2014-10-01
• First posted: 2014-04-09
• Last updated: 2021-05-18

Locations

1 site across 1 country: Brazil