Comparison of the effectiveness of biological amniotic membrane dressing with conventional ones in acute burn wounds in Ali-Ebne-Abitaleb hospital in Zahedan
Design
A randomized, blinded, clinical trial with a parallel group design of 100 patients, enrolled between February 2020 and February 2021.
Settings and conduct
The aim of this study is to compare the efficacy of biological amniotic membrane dressing with conventional dressing in acute burn wounds. Patients will be randomly divided into two groups: biological amniotic membrane dressing group and conventional dressing group . In first group, the dressing is from selective cesarean section deliveries in the Ali ibn Abitalib Hospital and in second group, silver sulfadiazine dressing will be used.
Patients in both groups will be matched for age, sex and burn percentage. Block randomization with blocks of 10. Considering the sample size of 50, 5 blocks will be selected; in each block there will be equal numbers of cards for each group. By selecting each block, 5 patients in each group will be selected. This is a double blinded study, Patients and outcome evaluator (trained nurse) will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All the patients with skin burn admitted to Ali Ibn Abi Talib Hospital in Zahedan in 2020
Exclusion criteria: Immune system disorder
Chronic diseases like : Diabetes Mellitus
Intervention groups
Intervention group 1: biological amniotic membrane dressing
Intervention group 2: conventional wound dressing
Main outcome variables
Burn Wound Infection
Times of Morphine administration
Duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191102045308N1
Registration date:2020-03-11, 1398/12/21
Registration timing:registered_while_recruiting
Last update:2020-03-11, 1398/12/21
Update count:0
Registration date
2020-03-11, 1398/12/21
Registrant information
Name
arsalan shirouyeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5576
Email address
dr.arsalanshirovyeh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-22, 1398/11/02
Expected recruitment end date
2020-04-21, 1399/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of biological amniotic membrane dressing with conventional ones in acute burn wounds
Public title
Comparison of the effectiveness of biological amniotic membrane dressing with conventional ones
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All the patients with skin burn admitted to Ali Ibn Abi Talib Hospital in Zahedan in 2020
Exclusion criteria:
Immune system disorder
Chronic diseases like : Diabetes Mellitus
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 10. Considering the sample size of 50, 5 blocks will be selected; in each block there will be equal numbers of cards for each group. By selecting each block, 5 patients in each group will be selected.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blinded study, Patients and outcome evaluator (trained nurse) will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences