Second-degree Burn
Conditions
Keywords
burns, dressings, silver sulfadiazine, silver compounds, cost
Brief 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.
Interventions
DRUGNanocrystalline 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.
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
Sponsors
University of Sorocaba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete epithelialization of the wound | 15 days | Proportion of lesions completely epithelialized during the specific time frame |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Direct medical and non-medical costs of treatment | 15 days | The medical and non-medical cost of the treatment comparing both dressings |
| Level of pain | 30 days | Level of pain associated with the application and removal of dressings |
| Number of dressing changes | 30 days | The number of dressing changes in the patients |
| Infection | 30 days | The incidence of infection |
| Adverse reactions | 90 days | Any adverse reactions caused by the silver dressings |
| Sugery | 90 days | The need for surgery |
Countries
Brazil
Outcome results
None listed