Back to resultsComparative Analysis of Cost-effectiveness of Silver Dressing in Burns (ARGENTUM)
Primary Purpose
Second-degree Burn
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Nanocrystalline silver
Silver Sulfadiazine
Sponsored by
About this trial
This is an interventional treatment trial for Second-degree Burn focused on measuring burns, dressings, silver sulfadiazine, silver compounds, cost
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.
Sites / Locations
- Clinic of the Burn Treatment of Sorocaba's Hospital Complex
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Nanocrystalline silver
Silver sulfadiazine
Arm 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.
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.
Outcomes
Primary Outcome Measures
Complete epithelialization of the wound
Proportion of lesions completely epithelialized during the specific time frame
Secondary Outcome Measures
Number of dressing changes
The number of dressing changes in the patients
Direct medical and non-medical costs of treatment
The medical and non-medical cost of the treatment comparing both dressings
Level of pain
Level of pain associated with the application and removal of dressings
Sugery
The need for surgery
Infection
The incidence of infection
Adverse reactions
Any adverse reactions caused by the silver dressings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02108535
Brief Title
Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
Acronym
ARGENTUM
Official Title
Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sorocaba
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Second-degree Burn
Keywords
burns, dressings, silver sulfadiazine, silver compounds, cost
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nanocrystalline silver
Arm Type
Experimental
Arm 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.
Arm Title
Silver sulfadiazine
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nanocrystalline silver
Other Intervention Name(s)
Acticoat
Intervention Description
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
Intervention Name(s)
Silver Sulfadiazine
Other Intervention Name(s)
Silvazine
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete epithelialization of the wound
Description
Proportion of lesions completely epithelialized during the specific time frame
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Number of dressing changes
Description
The number of dressing changes in the patients
Time Frame
30 days
Title
Direct medical and non-medical costs of treatment
Description
The medical and non-medical cost of the treatment comparing both dressings
Time Frame
15 days
Title
Level of pain
Description
Level of pain associated with the application and removal of dressings
Time Frame
30 days
Title
Sugery
Description
The need for surgery
Time Frame
90 days
Title
Infection
Description
The incidence of infection
Time Frame
30 days
Title
Adverse reactions
Description
Any adverse reactions caused by the silver dressings
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciane C Lopes, PhD
Organizational Affiliation
UNISO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of the Burn Treatment of Sorocaba's Hospital Complex
City
Sorocaba
State/Province
Sao Paulo
ZIP/Postal Code
18030-083.
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34688520
Citation
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.
Results Reference
derived
Learn more about this trial
Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
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