Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-03-02 @ 10:34 PM
Study NCT ID:
NCT02108535
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2014-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
Sponsor:
University of Sorocaba
Organization:
Study Overview
Official Title:
Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARGENTUM
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: