Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns (ARGENTUM)
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|ClinicalTrials.gov Identifier: NCT02108535|
Recruitment Status : Completed
First Posted : April 9, 2014
Last Update Posted : January 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Second-degree Burn||Drug: Nanocrystalline silver Drug: Silver Sulphadiazine||Phase 4|
Clinical trial, controlled, randomized, containing two parallel arms, the single center.
Adult patients between 18 and 65 years, regardless of sex, with second degree burns treated in an outpatient setting without the need for surgical treatment will be randomized (1:1) into two groups: silver sulfadiazine 1% on healing and the base nanocrystalline silver.
Primary endpoints include
- time to complete epithelialization of the wound
- proportions of lesions completely epithelialized over a period (15 days)
Secondary outcomes include:
- the number of dressing changes and the level of pain associated with your application and removal;
- direct medical costs and non-medical;
- need for surgery;
- incidence of infection;
- presence of adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||October 2014|
Experimental: 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.
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.
Other Name: Acticoat
Active Comparator: Silver sulphadiazine
Ranges for rayon containing cream 1% silver sulphadiazine 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 Sulphadiazine
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
Other Name: Silvazine
- complete healing of wound [ Time Frame: 15 days ]proportion of healed burns in the specific period
- Number of dressing changes [ Time Frame: 30 days ]the number of dressing changes in the patients
- Direct medical costs of treatment [ Time Frame: 15 days ]The medical cost of the treatment comparing all dressing
- pain [ Time Frame: 30 days ]Level of pain associated with the application and removal of dressings
- sugery [ Time Frame: 90 days ]the necessity of surgery;
- infection [ Time Frame: 30 days ]Incidence of infection
- adverse events [ Time Frame: 90 days ]any adverse events from silver dressing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108535
|Clinic of the Burn Treatment of Sorocaba's Hospital Complex|
|Sorocaba, Sao Paulo, Brazil, 18030-083.|
|Principal Investigator:||Luciane C Lopes, PhD||UNISO|