Comparison of the efficacy of topical silver sulfadiazine-cerium nitrate with silver sulfadiazine cream in in treatment of moderate and severe burns
Design
Randomized, single blind, superiority, parallel group trial
Settings and conduct
112 patients with burns in 2 and 3 degree referred to burn section of Imam Reza Hospital in Mashhad were randomly divided into two groups of silver sulfadiazine alone (56 patient) or silver sulfadiazine-cerium nitrate (56 patients) based on a four-block randomized blockade.
Silver sulfadiazine cream 1% will be prepared from commercially available products and silver sulfadiazine-cerium nitrate (1% and 2.2%) will be formulated in Mashhad Pharmacy Industrial Laboratory. All patients receive appropriate fluid and electrolyte and will be recorded after performing epithelialization rate assessment. 90% re-epithelialization will be considered as a complete repair.
The overall response to treatment will be determined by the outcome of the wound culture and the duration of skin epithelization or preparation for the transplant.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.Second and third degree burns based on the Laund & criterion.
2.Minimum burn rate of patients is 10% and maximum of 50%
3.Age 18-70 years
Intervention groups
In the intervention group: The topical therapy with the formulation of silver sulfadiazine-cerium nitrate 2.2% as long as the relative thickness of the burn is completely cured
In standard group: daily use of silver sulfadiazine topical formulation
Main outcome variables
Primary outcomes: The Re-epithelialization rate based on number of days (90% re-epithelialization will be considered as a complete repair).
secondary outcome: pain assessment based on visual pain manual scale, duration of hospitalization and infection frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190927044902N1
Registration date:2020-01-05, 1398/10/15
Registration timing:registered_while_recruiting
Last update:2020-01-05, 1398/10/15
Update count:0
Registration date
2020-01-05, 1398/10/15
Registrant information
Name
Emad Molaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 8478
Email address
molaeie942@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of topical silver sulfadiazine-cerium nitrate with silver sulfadiazine cream in in treatment of moderate and severe burns
Public title
Effect of topical silver sulfadiazine-cerium nitrate in treatment of moderate to severe burn
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Second and third degree burns according to Laund & Browder criteria
Minimum burn rate of patients is 10% and maximum of 50%
Patients are being hospitalized in the first 24 hours of a hospital bed.
informed consent to enter the study .
Exclusion criteria:
Inhalation burn
Electrical and chemical burns
Burns on face and hands and perineum
A history of known allergies to sulfonamides
History of Methemoglobinemia
Pregnancy and lactation
G6PD deficiency
Oliguria and Anuria
Functional liver disorders
Lack of satisfaction with the patient to enter or continue intervention
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with randomization list prepared from site randomization.com
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient, the treating physician and the evaluator are due to the different appearance of the formulation on the wound aware of the type of formulation (cerium nitrate will have a yellow-green appearance that produces a relatively dry scar while Silver sulfadiazine produces a damp matrix scar). They cannot be blind to the type of treatment. But the data analyzer will remain unaware of the grouping of patients until the end of the analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences