The aim of this study was to compare the efficacy of amniotic membrane dressing with nitrofurazone-impregnated dressing in healing second-degree burn
Design
The research was conducted as a single-center, double-blind randomized clinical trial (RCT) in Trauma and Burn Center of Imam Khomeini teaching Hospital in Urmia. The main objective of the study was to compare the dressing by amniotic membrane versus nitrofurazone-impregnated gauze in the treatment of second-degree burnsamong burn patients.
Settings and conduct
In the first group, the amniotic membrane donated by the hospital was used to dress the superficial second-degree wound. Petroleum-impregnated gauze and wet gauze were placed on amniotic membrane and bandaged. In the dressing group with nitrofurazone-impregnated gauze, 20 g of ointment per burn percentage was used. Then, relevant variables were collected in a checklist for all patients.
Participants/Inclusion and exclusion criteria
The inclusion criterion was presence of superficial second-degree burn
Intervention groups
45 patients entered the first group (amnioticmembrane dressing) and 42 patients entered the second group (nitrofurazone ointment-impregnated gauze).
Main outcome variables
The study endpoints were as follows: extent of wound infection, severity of pain in the dressing site, level of epithelialization, number of days needed for epithelialization of superficial second-degree burn wound as well as hospitalization period, frequency of dressing changes, analgesic use, and wound scarring rate of patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181216041996N1
Registration date:2019-01-22, 1397/11/02
Registration timing:registered_while_recruiting
Last update:2019-01-22, 1397/11/02
Update count:0
Registration date
2019-01-22, 1397/11/02
Registrant information
Name
AFSHIN ZAHEDI
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3348 0098
Email address
dr.afshinz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dressing with Amniotic membrane and Nitrofurazone ointment in second degree burn wound in THE IMAM KHOMEYNI hospital of URMIA
Public title
Comparison of dressing with Amniotic membrane and Nitrofurazone ointment in second degree burn wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
superficial second-degree burn in all age groups
Exclusion criteria:
unstable vital signs,
history of psychiatric disorders in patients with burns
smoking, drug and psychotropic substance addiction
history of heart, kidney, and liver diseases, diabetes, malnutrition,
history of corticosteroids or immunosuppressive drugs use,
inhalation and old burns
evidence of infection in burns
reaction and hypersensitivity to nitrofurazone ointment as well as to dressing with amniotic membrane
need for wound debridement in operation room
non-referral of patients after hospital discharge
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the sequences were assigned by an independent researcher using random allocation software version 1 (reference No.21) in permuted blocks of 2 or 4. At the time of randomization, a nurse who was not involved in the study process or care of patients opened a numbered envelope containing patient allocation sheets in one of the two study groups, and the participants were thus assigned to any of the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blindness, the type of treatment (amniotic membrane and nitrofurazone ointment) was only determined by the first researcher, and the second researcher who was involved in collecting information and completing the checklist had no knowledge of treatment type, prescription, and patient group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of medical sciences
Street address
Imam Khomeini Hospital Ershad street
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
IR.UMSU.REC.1397.245
Health conditions studied
1
Description of health condition studied
superficial second-degree burns
ICD-10 code
M61.30
ICD-10 code description
Calcification and ossification of muscles associated with burns, unspecified site
Primary outcomes
1
Description
wound infection
Timepoint
seventh, fourteenth, and thirtieth days
Method of measurement
observation . examination
2
Description
, severity of pain in the dressing site
Timepoint
first 7 days
Method of measurement
The severity of pain was measured using Visual Analogue Scale 0 to 10 numeric pain distress scale- on which the patient left marks based on their pain sensation
3
Description
level of epithelialization
Timepoint
seventh, fourteenth, and thirtieth days
Method of measurement
observation
4
Description
hospitalization period
Timepoint
hospitalization period
Method of measurement
observation
5
Description
frequency of dressing changes
Timepoint
first 7 days
Method of measurement
observation
6
Description
analgesic use
Timepoint
first 7 days
Method of measurement
observation
7
Description
wound scarring rate
Timepoint
seventh, fourteenth, and thirtieth days
Method of measurement
Vancouver scar score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the amniotic membrane donated by the hospital was used to dress the superficial second-degree wound
Category
Treatment - Drugs
2
Description
Control group: In the dressing group with nitrofurazone-impregnated gauze, 20 g of ointment per burn percentage was used
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Imam Khomeini Hospital
Full name of responsible person
Afshin Zahedi
Street address
Urmia Imam Khomeini Hospital Ershad street
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
dr.afshinz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Afshin Zahedi
Street address
Urmia University of Medical Sciense Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
dr.afshinz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Afshin Zahedi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Urmia Imam Khomeini Hospital Ershad street
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
dr.afshinz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Jafar Kazemzadeh
Position
Consultant
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Urmia Imam Khomeini Hospital Ershad street
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
jafarkazemzade48@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Afshin Zahedi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Urmia Imam Khomeini Hospital Ershad street
City
Urmia
Province
West Azarbaijan
Postal code
5715789397
Phone
+98 44 3346 9931
Email
dr.afshinz@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available