Clinical trial NCT02108535: Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
Official title: Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Second-degree Burn
Keywords: burns
dressings
silver sulfadiazine
silver compounds
cost
Lead sponsor: University of Sorocaba
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Complete epithelialization of the wound
timeFrame: 15 days
Secondary outcomes:
measure: Number of dressing changes
timeFrame: 30 days
measure: Direct medical and non-medical costs of treatment
timeFrame: 15 days
measure: Level of pain
timeFrame: 30 days
measure: Sugery
timeFrame: 90 days
measure: Infection
timeFrame: 30 days
measure: Adverse reactions
timeFrame: 90 days
Other outcomes:
Locations:
city: Sorocaba
country: Brazil
facility: Clinic of the Burn Treatment of Sorocaba's Hospital Complex
state: Sao Paulo
Study officials:
affiliation: UNISO
name: Luciane C Lopes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.