Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns

Phase 4

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Nanocrystalline silver	Nanocrystalline silver	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	Silver Sulfadiazine	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.

Primary Outcome Measures

Name	Time	Method
Complete epithelialization of the wound	15 days	Proportion of lesions completely epithelialized during the specific time frame

Secondary Outcome Measures

Name	Time	Method
Sugery	90 days	The need for surgery
Adverse reactions	90 days	Any adverse reactions caused by the silver dressings
Direct medical and non-medical costs of treatment	15 days	The medical and non-medical cost of the treatment comparing both dressings
Infection	30 days	The incidence of infection
Number of dressing changes	30 days	The number of dressing changes in the patients
Level of pain	30 days	Level of pain associated with the application and removal of dressings

Locations (1): Clinic of the Burn Treatment of Sorocaba's Hospital Complex
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Sorocaba, Sao Paulo, Brazil