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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
Sponsor:
Information provided by (Responsible Party):
Luciane Cruz Lopes, University of Sorocaba

Brief Summary:
The evidence is insufficient to determine whether the types of dressings containing silver differ as the time/proportion to complete healing of the wound and pain. We will analyze cost-effectiveness of these dressings in outpatients, considering the service provided by the National Public Health System.

Condition or disease Intervention/treatment Phase
Second-degree Burn Drug: Nanocrystalline silver Drug: Silver Sulphadiazine Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. complete healing of wound [ Time Frame: 15 days ]
    proportion of healed burns in the specific period


Secondary Outcome Measures :
  1. Number of dressing changes [ Time Frame: 30 days ]
    the number of dressing changes in the patients

  2. Direct medical costs of treatment [ Time Frame: 15 days ]
    The medical cost of the treatment comparing all dressing

  3. pain [ Time Frame: 30 days ]
    Level of pain associated with the application and removal of dressings

  4. sugery [ Time Frame: 90 days ]
    the necessity of surgery;

  5. infection [ Time Frame: 30 days ]
    Incidence of infection

  6. adverse events [ Time Frame: 90 days ]
    any adverse events from silver dressing



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults between 18 and 65 years;
  • regardless of sex and race,
  • second degree burns (partial thickness), ie, involving the epidermis and part of the dermis, with at least the preservation of some dermal appendages from of which the wound may possibly be epithelialized spontaneously (ARTZ; Moncrief; PRITT, 1980) that required treatment in an outpatient setting 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,
  • mentally disabled,
  • with burns to the face or face and hands before the planting of the feet, as it was felt that there is need for specific treatment to prevent functional sequelae.
  • Patients who have already started treatment at other institutions,
  • those who arrived after the 5th day of the burn or
  • unable to sign the consent form or who declined to participate.

Information from the National Library of Medicine

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


Locations
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Brazil
Clinic of the Burn Treatment of Sorocaba's Hospital Complex
Sorocaba, Sao Paulo, Brazil, 18030-083.
Sponsors and Collaborators
University of Sorocaba
Investigators
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Principal Investigator: Luciane C Lopes, PhD UNISO

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Responsible Party: Luciane Cruz Lopes, Professor - Researcher, University of Sorocaba
ClinicalTrials.gov Identifier: NCT02108535     History of Changes
Other Study ID Numbers: UNISO-2012
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Luciane Cruz Lopes, University of Sorocaba:
burns
dressings
silver sulfadiazine
silver compounds
cost
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Sulfadiazine
Silver Sulfadiazine
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Anti-Infective Agents, Local