Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns (ARGENTUM)

University of Sorocaba

Status and phase: Completed; Phase 4

Conditions: Second-degree Burn

Treatments: Drug: Nanocrystalline silver; Drug: Silver Sulfadiazine

Study type: Interventional

Funder types: Other

Identifiers

NCT02108535

UNISO-2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Nanocrystalline silver

Experimental group

Description:

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.

Treatment:

Drug: Nanocrystalline silver

Silver sulfadiazine

Active Comparator group

Description:

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.

Treatment:

Drug: Silver Sulfadiazine