Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns

NCT02108535 | Completed Phase 4

• 1 other identifier: UNISO-2012
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Second-degree Burn

Keywords

burns; dressings; silver sulfadiazine; silver compounds; cost

Outcome Measures

Primary Outcomes (1)

• Complete epithelialization of the wound

  Proportion of lesions completely epithelialized during the specific time frame

  15 days

Secondary Outcomes (6)

• Number of dressing changes

  30 days

• Direct medical and non-medical costs of treatment

  15 days

• Level of pain

  30 days

• Sugery

  90 days

• Infection

  30 days

Study Arms (2)

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.

Drug: Nanocrystalline silver

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.

Drug: Silver Sulfadiazine

Interventions

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.

Also known as: Acticoat

Nanocrystalline silver

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

Also known as: Silvazine

Silver sulfadiazine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sorocaba: lead

Study Sites (1)

Clinic of the Burn Treatment of Sorocaba's Hospital Complex

Sorocaba, São Paulo, 18030-083., Brazil

Location

Related Publications (1)

• 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.

  PMID: 34688520 DERIVED

MeSH Terms

Conditions

Burns

Interventions

Acticoat; Silver Sulfadiazine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sulfadiazine; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Luciane C Lopes, PhD

  UNISO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Researcher

Study Record Dates

• First Submitted: April 5, 2014
• First Posted: April 9, 2014
• Study Start: November 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)