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Completed

NCT Number: NCT02108535

Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinic of the Burn Treatment of Sorocaba's Hospital Complex

Sorocaba, São Paulo, 18030-083., Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nanocrystalline silver

Drug

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 names: Acticoat

Silver Sulfadiazine

Drug

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 names: Silvazine

Primary outcomes

  1. Complete epithelialization of the wound

    Time frame: 15 days

    Proportion of lesions completely epithelialized during the specific time frame

Secondary outcomes

  1. Number of dressing changes

    Time frame: 30 days

    The number of dressing changes in the patients

  2. Direct medical and non-medical costs of treatment

    Time frame: 15 days

    The medical and non-medical cost of the treatment comparing both dressings

  3. Level of pain

    Time frame: 30 days

    Level of pain associated with the application and removal of dressings

  4. Sugery

    Time frame: 90 days

    The need for surgery

  5. Infection

    Time frame: 30 days

    The incidence of infection

  6. Adverse reactions

    Time frame: 90 days

    Any adverse reactions caused by the silver dressings

Sponsors and collaborators

Lead sponsor

University of Sorocaba

Other

Registry information

Acronym: ARGENTUM

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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