Determining the effectiveness of laminar membrane of hydatid cyst and amnion on the treatment of burn patients - phase 2 clinical trial.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3-2 on 60 patients. A computer program is used for randomization.
Settings and conduct
This project is carried out in the burn department of Shefa Hospital in Kerman. It is performed on 60 patients with burns in a double blind manner, in which both patients and evaluators are unaware of the type of treatment. An independent person not involved in the evaluations will be responsible for the preparation and dressing. All dressings are prepared in packs of the same color and the same size so that they are not recognizable from each other. Coding of the treatments is done by an independent person and the code key remains confidential until the end of the study and data analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18 and above; 1st or 2nd degree burns; Patients willing to sign the informed consent form.
Exclusion criteria: Patients who have a history of uncontrolled underlying diseases and have cancer; Patients with active infection; Patients whose status cannot be followed up regularly; including those with serious psychiatric disorders.
Intervention groups
Intervention group1(20 people): treatment with laminar membrane; Intervention group2 (20 people): treatment with amniotic membrane; Control group (20 people): usual treatments.
Main outcome variables
The surface of wound, the size of the granulation tissue, pain, the frequency of wound infection and complications, the scar after the wound.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240730062589N1
Registration date:2024-08-25, 1403/06/04
Registration timing:prospective
Last update:2024-08-25, 1403/06/04
Update count:0
Registration date
2024-08-25, 1403/06/04
Registrant information
Name
Ali derakhshani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 7307
Email address
a.derakhshani@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison and effectiveness of laminar membrane of hydatid cyst and amnion on the treatment of burn patients - phase 2 clinical trial.
Public title
Investigating the effect of laminar membrane on burn treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
First or second degree burns
Patients willing to sign an informed consent form.
Age 18 years and above
Exclusion criteria:
Patients with 3rd degree and severe burns.
Patients who have a history of uncontrolled underlying diseases
Patient with cancer
Patients with active infection
Patients whose status cannot be followed up regularly, including those with serious psychiatric disorders.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A computerized randomization software (such as Research Randomizer) is used to generate random lists. Patients are randomly divided into three groups: group A (exosome), group B (PRP) and group C (control). A randomized block method with blocks of 6 is used to maintain a balanced distribution between groups. Random codes are placed in sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is conducted in a double-blind manner, that is, both patients and evaluators are unaware of the type of treatment.
An independent person not involved in the evaluations will be responsible for the preparation and dressing. All dressings are prepared in packs of the same color and the same size so that they are not recognizable. Coding of the treatments is done by an independent person and the key of the codes remains confidential until the end of the study and data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Hydatid Disease Research Center, Afzalipour Medical School, Shahid Bahonar University, Pajoohesh Square, 22 Bahman Street
City
Kerman
Province
Kerman
Postal code
7616914115
Approval date
2024-07-22, 1403/05/01
Ethics committee reference number
IR.KMU.REC.1403.157
Health conditions studied
1
Description of health condition studied
Burn of first degree
ICD-10 code
T30.1
ICD-10 code description
Burn of first degree, body region unspecified
2
Description of health condition studied
Burn of first degree
ICD-10 code
T30.2
ICD-10 code description
Burn of first degree, body region unspecified
Primary outcomes
1
Description
The size of the damaged area
Timepoint
Every other day until recovery
Method of measurement
Imaging and analysis in j Image software
2
Description
Wound healing percentage over time
Timepoint
Every other day until recovery
Method of measurement
Imaging and analysis in j Image software
3
Description
Pain from a burn wound
Timepoint
Every other day until recovery
Method of measurement
Asking from the patient
4
Description
Bacterial infection or complications of the wound
Timepoint
Every other day until recovery
Method of measurement
Observation
5
Description
How to heal scars
Timepoint
Every other day until recovery
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: laminar membrane prepared from hydatid cyst in a completely sterile form, which is changed daily for 2 weeks.
Category
Treatment - Other
2
Description
Intervention group 2: the amniotic membrane prepared from the placenta in a completely sterile manner, which is changed daily for 2 weeks.
Category
Treatment - Other
3
Description
Control group: standard and routine treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Majid Fasihi Harandi
Street address
Shefa Hospital, North Farabi Street
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3211 7307
Email
majid.fasihi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Hydatid Disease Research Center, Afzalipour Medical School, Shahid Bahonar University, Pajoohesh Square, 22 Bahman Street
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3211 7307
Email
majid.fasihi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Majid Fasihi Harandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Hydatid Disease Research Center, Afzalipour Medical School, Shahid Bahonar University, Pajoohesh Square, 22 Bahman Street
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3211 7307
Email
majid.fasihi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Majid Fasihi Harandi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Parasitology
Street address
Hydatid Disease Research Center, Afzalipour Medical School, Shahid Bahonar University, Pajoohesh Square, 22 Bahman Street
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3211 7307
Email
majid.fasihi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ali Derakhshani
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Hydatid Disease Research Center, Afzalipour Medical School, Shahid Bahonar University, Pajoohesh Square, 22 Bahman Street
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3211 7307
Fax
Email
a.derakhshani@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Main outcome data for each patient will be reported, such as recovery time and pain level, etc
When the data will become available and for how long
After printing the results
To whom data/document is available
For all researchers and applicants approved by the Hydatid Disease Research Center
Under which criteria data/document could be used
Six months after the publication of the article, participants and researchers approved by the research center can access the final data by email or by referring the Hydatid Disease Research Center.
From where data/document is obtainable
They can refer to Dr. Fasihi Herandi at the Hydatid Disease Research Center
What processes are involved for a request to access data/document
After the person's identity is authenticated and confirmed by the Hydatid Disease Research Center, the information is made available to the applicant.