Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns

University of Sorocaba100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Second-degree Burn

Interventions

Nanocrystalline silverDRUG

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.

Silver SulfadiazineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults aged between 18 and 65 years; * Regardless of sex and ethnicity; * Presenting second degree burns (partial thickness involving the epidermis and part of the dermis, with at least the preservation of some dermal appendages from of which the wound can eventually be epithelialized spontaneously) (ARTZ; MONCRIEF; PRITT, 1980) under an outpatient regimen, without the need for surgical debridement of devitalized tissue and skin grafts informed in the initial clinical diagnosis. Exclusion Criteria: * Patients with diabetes; * Pregnant women; * Patients with intellectual disabilities; * Patients with burns to the face or on the palmar face of the hands or on the plantar face of the feet, as the need for specific treatment was felt to prevent functional sequelae; * Patients who have already started treatment in other institutions; * Those whose burns had happened 5 or more days before their entrance in the hospital; * Those incapable of signing the informed consent form or who have declined to participate.

Locations (1)

Clinic of the Burn Treatment of Sorocaba's Hospital Complex

Sorocaba, São Paulo, Brazil

Outcomes

Primary Outcomes

Complete epithelialization of the wound

Proportion of lesions completely epithelialized during the specific time frame

Time frame: 15 days

Secondary Outcomes

Number of dressing changes

The number of dressing changes in the patients

Time frame: 30 days

Direct medical and non-medical costs of treatment

The medical and non-medical cost of the treatment comparing both dressings

Time frame: 15 days

Level of pain

Level of pain associated with the application and removal of dressings

Time frame: 30 days

Sugery

The need for surgery

Time frame: 90 days

Infection

The incidence of infection

Time frame: 30 days

Adverse reactions

Any adverse reactions caused by the silver dressings

Time frame: 90 days

Data from ClinicalTrials.gov

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