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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanocrystalline silver | Experimental | Flexible polyester low-grip coated nanocrystalline silver dressing. The dressing was applied to the lesion after being soaked in sterile distilled water. About this compresses to bandage movements will have been added and comes to avoid tourniquet bandage on-site maintenance, temperature of the affected area, cushioning and absorption of wound exudate when present. Is finished with the application of crepe bandages in the form of flakes containment curative and maintenance of pressure. This procedure aids in the bloodstream, and avoids the increased edema. The bandage is started from the periphery to the central region, avoiding tourniquet. The exchanges were performed every three days. |
|
| Silver sulfadiazine | Active Comparator | Ranges for rayon containing cream 1% silver sulfadiazine were used. Involving this layer, bandages for dressings were added in movements back and forth to avoid the tourniquet, providing maintenance of the temperature of the affected area, cushioning and absorption of wound exudate when present. This application was completed with crepe bandages to contain the dressing and maintain pressure. This procedure aids in the bloodstream, and avoids the increased edema. The bandage is started from the periphery to the central region, scales, avoiding the tourniquet. Dressing changes were performed daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanocrystalline silver | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete epithelialization of the wound | Proportion of lesions completely epithelialized during the specific time frame | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of dressing changes | The number of dressing changes in the patients | 30 days |
| Direct medical and non-medical costs of treatment | The medical and non-medical cost of the treatment comparing both dressings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luciane C Lopes, PhD | UNISO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic of the Burn Treatment of Sorocaba's Hospital Complex | Sorocaba | São Paulo | 18030-083. | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34688520 | Derived | Moreira SS, Camargo MC, Caetano R, Alves MR, Itria A, Pereira TV, Lopes LC. Efficacy and costs of nanocrystalline silver dressings versus 1% silver sulfadiazine dressings to treat burns in adults in the outpatient setting: A randomized clinical trial. Burns. 2022 May;48(3):568-576. doi: 10.1016/j.burns.2021.05.014. Epub 2021 Jun 1. |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C117408 | Acticoat |
| D012837 | Silver Sulfadiazine |
| ID | Term |
|---|---|
| D013411 | Sulfadiazine |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
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|
|
| Silver Sulfadiazine | Drug | 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 |
|
|
| 15 days |
| Level of pain | Level of pain associated with the application and removal of dressings | 30 days |
| Sugery | The need for surgery | 90 days |
| Infection | The incidence of infection | 30 days |
| Adverse reactions | Any adverse reactions caused by the silver dressings | 90 days |
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |