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

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.

Study Overview

• Status: Completed
• Conditions: Second-degree Burn
• Intervention / Treatment: Drug: Nanocrystalline silver; Drug: Silver Sulfadiazine

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Sorocaba, Sao Paulo, Brazil, 18030-083.
      • Clinic of the Burn Treatment of Sorocaba's Hospital Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Nanocrystalline 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.; Other Names: Acticoat
Active Comparator: 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.	Drug: Silver Sulfadiazine; 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; Other Names: Silvazine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete epithelialization of the wound	Proportion of lesions completely epithelialized during the specific time frame	15 days

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Sorocaba
• Investigators: Principal Investigator: Luciane C Lopes, PhD, UNISO

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 5, 2014
• First Submitted That Met QC Criteria: April 5, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 15, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: burns; dressings; cost; silver sulfadiazine; silver compounds
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Coccidiostats; Sulfadiazine; Silver Sulfadiazine
• Other Study ID Numbers: UNISO-2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO