Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns

Second-degree Burn Clinical Trial

— ARGENTUM  

Official title:

Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108535
• Other study ID #: UNISO-2012
• Status: Completed
• Phase: Phase 4
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2021
• Source: University of Sorocaba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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.

Related Conditions & MeSH terms

• Burns
• Second-degree Burn

Intervention

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.
• 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

Locations

Country	Name	City	State
Brazil	Clinic of the Burn Treatment of Sorocaba's Hospital Complex	Sorocaba	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sorocaba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete epithelialization of the wound	Proportion of lesions completely epithelialized during the specific time frame	15 days
Secondary	Number of dressing changes	The number of dressing changes in the patients	30 days
Secondary	Direct medical and non-medical costs of treatment	The medical and non-medical cost of the treatment comparing both dressings	15 days
Secondary	Level of pain	Level of pain associated with the application and removal of dressings	30 days
Secondary	Sugery	The need for surgery	90 days
Secondary	Infection	The incidence of infection	30 days
Secondary	Adverse reactions	Any adverse reactions caused by the silver dressings	90 days