Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns

NCT ID: NCT02108535

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-10-31

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.

Conditions

Second-degree Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Nanocrystalline silver

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Silver Sulfadiazine

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Acticoat; Silvazine

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sorocaba

OTHER

Sponsor Role: lead

Responsible Party

Luciane Cruz Lopes

Professor - Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luciane C Lopes, PhD

Role: PRINCIPAL_INVESTIGATOR

UNISO

Locations

Clinic of the Burn Treatment of Sorocaba's Hospital Complex

Sorocaba, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 34688520 (View on PubMed)

Other Identifiers

UNISO-2012

Identifier Type: -

Identifier Source: org_study_id