Second-degree BurnPhase 4ARGENTUMNCT02108535
Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
A Phase 4 study testing Nanocrystalline silver and Silver Sulfadiazine in people with Second-degree Burn, run by University of Sorocaba at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Second-degree Burn
- What is being tested?
- Nanocrystalline silver and Silver Sulfadiazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinic of the Burn Treatment of Sorocaba's Hospital Complex
Sorocaba, São Paulo, 18030-083.
About this study
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.
Read the 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
- Being tested
- Nanocrystalline silver, Silver Sulfadiazine
- Keywords
- burns, dressings, silver sulfadiazine, silver compounds, cost
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanocrystalline silverDrug
Also called Acticoat
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 SulfadiazineDrug
Also called Silvazine
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Silver Sulfadiazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete epithelialization of the wound
Proportion of lesions completely epithelialized during the specific time frame
Measured: 15 days
Secondary outcomes (6)
Number of dressing changes
The number of dressing changes in the patients
Measured: 30 days
Direct medical and non-medical costs of treatment
The medical and non-medical cost of the treatment comparing both dressings
Measured: 15 days
Level of pain
Level of pain associated with the application and removal of dressings
Measured: 30 days
Sugery
The need for surgery
Measured: 90 days
Infection
The incidence of infection
Measured: 30 days
Adverse reactions
Any adverse reactions caused by the silver dressings
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Second-degree BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sorocaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luciane Cruz Lopes, University of Sorocaba
- Investigators
- Luciane C Lopes, PhD, Principal investigator, UNISO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108535
- Sponsor's protocol ID
- UNISO-2012
- Acronym
- ARGENTUM
- Status last verified
- May 2021
- First submitted
- 5 Apr 2014
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 34688520
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
- ClinicalTrials.gov ID
- NCT02108535
- Acronym / sponsor ID
- ARGENTUM / UNISO-2012
- Conditions
- Second-degree Burn
- Keywords
- burns, dressings, silver sulfadiazine, silver compounds, cost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of SorocabaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nanocrystalline silver | Experimental | Drug: Nanocrystalline silverFlexible 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. |
| Silver sulfadiazine | Active comparator | Drug: Silver SulfadiazineRanges 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nanocrystalline silverAlso: ActicoatFlexible 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. | Drug | Nanocrystalline silver |
| Silver SulfadiazineAlso: SilvazineThis 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 | Drug | Silver sulfadiazine |
Primary outcome
Complete epithelialization of the wound
Time frame: 15 days
Proportion of lesions completely epithelialized during the specific time frame
6 secondary outcomes
Number of dressing changes
Time frame: 30 days
Direct medical and non-medical costs of treatment
Time frame: 15 days
Level of pain
Time frame: 30 days
Sugery
Time frame: 90 days
Infection
Time frame: 30 days
Adverse reactions
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 34688520Moreira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciane C Lopes, PhD principal investigator
UNISO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nanocrystalline silver and Silver Sulfadiazine in people with Second-degree Burn, run by University of Sorocaba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete epithelialization of the wound (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02108535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.