The effect of egg white formulation on bed sore healing
Design
Clinical trial with an intervention group and a control group, three-sided, randomized, phase three on 78 patients, randomization will be performed with WinPepe software.
Settings and conduct
The subjects, researchers and analysts were all blind in this study. The method of blinding is that the drug maker numbers the container containing the drug and the placebo with numbers 1 and 2 . The researcher uses each number for an intervention or control group while being unaware of the contents of the container. This study is performed in Imam and Golestan hospitals of Ahvaz.
Participants/Inclusion and exclusion criteria
1. Age over 18 years
2. Clinical diagnosis of grade 2 and 3 pressure ulcers
3. Hospitalized in the intensive care unit of Golestan and Imam hospitals in Ahvaz
4. Antibiotic use was the same in both groups
5. Absence of cancer
6. Do not use immunosuppressants
7. Absence of chronic diseases that are in the process of treatment of diseases such as disease, severe diseases, lupus, rheumatoid arthritis and kidney failure, which is determined by the patient's medical history and file.
Intervention groups
The intervention includes dressing patients' wounds according to the procedure of changing the hospital dressing. Egg white formula is used in the intervention group and placebo in the control group with phenytoin cream or camphile depending on the doctor's prescription and the wound is bandaged. Wounds are then examined at the end of each week for four weeks according to pressure criteria. Sampling is done by the researcher. Scoring is done by three observers, two observers with direct observation and one with photo.
Main outcome variables
Reducing the duration and treatment costs of pressure ulcers, increasing the quality of life of patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220522054960N1
Registration date:2022-06-12, 1401/03/22
Registration timing:prospective
Last update:2022-06-12, 1401/03/22
Update count:0
Registration date
2022-06-12, 1401/03/22
Registrant information
Name
Atefeh Tadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3372 4813
Email address
atefehtadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of egg white formulation on bed sore healing
Public title
The effect of egg white formulation on bed sore healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age over 18 years
2. Clinical diagnosis of grade 2 and 3 pressure ulcers
3. Hospitalized in the intensive care unit of Golestan and Imam Ahvaz hospitals
4. Antibiotic use was the same in both groups
5. No cancer
6. Do not use immunosuppressants
7. Do not have chronic diseases that affect the wound healing process, such as diabetes, severe vascular disease, lupus, rheumatoid arthritis and kidney failure, which is determined by the patient's medical history and record.
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to intervention and control groups will be done by block random method using 6 blocks. In each block, 3 people will be in the intervention group and 3 people in the control group, but the order of placement will be It will be a random form that will be done with WinPepi software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, the manufacturer of the formulation numbered the container containing the drug formula and the placebo, while none of the participants in the study included the researcher, clinical caregiver, outcome assessor, data analyst, and content monitoring committee. Every dish is unknowingly studied.
Placebo
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Alley, Esfand St., Ahvaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.AJUMS.REC.1401.066
Health conditions studied
1
Description of health condition studied
Compression ulcer, which is a disorder of skin cohesion, occurs due to the compression of the soft tissue between the skeletal joints and an external surface such as the bed or chair.
ICD-10 code
L89
ICD-10 code description
Pressure ulcer
Primary outcomes
1
Description
Wound healing is the healing and return of complete health to the damaged tissue in this study Acupressure wound healing means that according to the standard dressing checklist, the score given to the wound is reduced compared to the initial score (week zero).
Timepoint
End each week for four weeks
Method of measurement
Wound measurement and control tools, which consist of three criteria: wound size, amount of secretions and type of tissue, examine the wound and determine the wound healing status by combining these three criteria. In this checklist, the extent of the wound is 10-0. The amount of wound discharge is 0-3 and the type of wound tissue is 0-4. A score of zero indicates wound healing and a highest score of 17 indicates wound healing.
Secondary outcomes
empty
Intervention groups
1
Description
This study examined second- and third-degree wounds and none of the patients are deprived of their main treatment, which is a daily dressing with phenytoin ointment or camphil dressing. The treatment protocol is such that patients' wound dressings are changed daily according to the hospital dressing routine. In this way, after preparing the dressing changing equipment, including sterile gloves, sterile gauze, washing serum, sterilized changing dressing set and hand glue with washed water and soap, then the previous dressing is removed along with the process of changing the previous dressing position. The wound is examined ، After wearing sterile gloves, the wound is washed with serum and dried with sterile gauze. Then, the egg white formulation is used in the intervention group and placebo in the control group with phenytoin cream or camphile, depending on the doctor's prescription. The wound is bandaged. Wounds are then examined at the end of each week for four weeks according to push criteria. Using the push tool, three criteria of wound size, amount of secretions and type of tissue formed in the wound are detected and scored. Sampling of samples in both intervention and control groups is performed by the researcher. Because environmental factors may affect the observer, two observers are used to score in the observed position. In order to prevent bias from the wounds of patients in the treatment process, digital photos are taken and the photos are examined by the third observer, who is not aware of the type of dressing, in terms of the healing process. The observer is required to read the completed questionnaire for patients as soon as possible after observation, in order to avoid inconsistencies and ambiguities due to the time interval between observation and study.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Meisam Moezi
Street address
Golestan hospital, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3009
Email
golestanhospital@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Reza Akhondzadeh
Street address
Imam khomeini hospital. Azadegan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
7311161936
Phone
+98 61 3292 3985
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mrs Zakerkish
Street address
Ahwaz University of Medical Sciences, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 4114
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Tadi
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 10, Karun 3 Complex, between Dey and Bahman St, Shahrivar St, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135935700
Phone
+98 38 3372 4813
Email
atefehtadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Tadi
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 10, Karun 3 Complex, between Dey and Bahman St, Shahrivar St, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135935700
Phone
+98 38 3372 4813
Email
atefehtadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Atefeh Tadi
Position
Graduate student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 10, Karun 3 Complex, between Dey and Bahman St, Shahrivar St, Golestan.
City
Ahvaz
Province
Khouzestan
Postal code
6135935700
Phone
+98 38 3372 4813
Email
atefehtadi@yaoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
A large part of the data such as information about the main outcome, how to do, etc. can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
All researchers
Under which criteria data/document could be used
By observing the ethics of research
From where data/document is obtainable
Atefeh Tadi atefehtadi@yahoo.com
What processes are involved for a request to access data/document
Send the request to the email and receive the answer within two weeks after authentication.