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The effect of topical formulation containing egg whites on healing of second degree wound in burn patients

Protocol summary

Summary
The present study is a triangular clinical trial with the aim of determining the effect of topical formulation of egg whites on the improvement of second-degree burn wounds. In this study, the research environment of Taleghani Hospital in Ahvaz is located in Ahwaz, Iran. The study population includes all male and female patients with confirmed diagnosis of grade II burns. The sample size is estimated on the basis of statistical calculations of 90 people who are randomly assigned to two groups (45 persons). Intervention and control are assigned. The therapeutic protocol is this. Second degree ocular lesions, the blister is completely intact, remains intact in the second degree wound, which is usually blotted out, after removing the blisters and dead tissues, and after Daily rinses with normal saline, exposed to air for 5 minutes, to dry. Then, 1% silver sulfadiazine silver ointment is placed on the wound by a sterile abscess of 5 mm size. After 1 hour, without wound healing in the intervention group, a sterile abscess of 5 mm formulation Place the egg white on the wound and dressing. And in the control group, we rub and place the placebo on the wound with a sterile abscess of about 5 milligrams of the placebo.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017053134262N1
Registration date: 2017-08-07, 1396/05/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-08-07, 1396/05/16
Registrant information
Name
hadis ashrafizadeh
Name of organization / entity
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 933 504 7127
Email address
ashrafizadeh.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ahvaz Jundishapur University of medical sciences.
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2017-10-10, 1396/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical formulation containing egg whites on healing of second degree wound in burn patients
Public title
The effect of topical formulation containing egg whites on healing of second degree wound in burn patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Second degree burns confirmed by the doctor; The age is between 18-60 years; burn percentage is less than 15 percent; It is not more than 6 hours from the time of the burn until it enters the research; Areas (face, genitals and perineum) are not included in the study due to the sensitivity of these areas; The amount of hemoglobin and total protein is in the normal range. The normal range of hemoglobin (the Ba18-14 in men and in women 16-12 grams per deciliter) and total protein (8.7 to 6.6 grams per deciliter); The patient's wound is not impregnated with contaminants; Before entering the study samples of any substance other than potable water is not used on wounds; Before entering the study, there is no sign of infection with different parts of the body; underlying immune deficiency diseases such as diabetes, cancer, AIDS, hypertension, malnutrition, etc. is not; The patient is not known to have a skin allergy; is able to respond to questions. Exclusion criteria: During the study, patients need to use immunosuppressive drugs, steroid drugs, chemotherapy drugs and radiation therapy; If there is any indication that an infected burn wounds treated. Any of these symptoms (edema in the area burned along with induration and inflammation of the edges of the wound, discoloration wound burned to dark red, brown, purple, black, presence of purulent discharge, foul-smelling, green and abundant, fever, during the course of treatment) in treated infected wounds and were removed from the sample study and treatment under doctor's supervision changes.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
Street address
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
City
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
Postal code
Approval date
2017-05-02, 1396/02/12
Ethics committee reference number
IR.AJUMS.REC.1396.146

Health conditions studied

1

Description of health condition studied
burn
ICD-10 code
949
ICD-10 code description
949

Primary outcomes

1

Description
burn wound
Timepoint
The first day / seven days / fifteenth day
Method of measurement
To measure wound plastic tape will be used, which is accurate to about 1: 1000 is. The admission to the clinic (first day) and during treatment seventh day and the fifteenth day, the extent of the wound by contact with a tape measure and guide the measurement of transparent measurement and the basis Length Width expressed, and Jensen wound assessment tool Bts- using parameters that are related to the extent of burn wound, the wound (ulcer depth), the edge of the wound, the destruction of underlying tissue, necrotic tissue, necrotic tissue, exudate, the exudate, color of the skin around the wound, peripheral tissue induration, edema peripheral tissues, tissue granulation and epithelialization by the researchers analyzed tissue M And according to points earned from it will be examined wound healing.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: Second degree ophthalmic ulcers remain intact and remain intact in the second grade wound, which are usually blisters, after removing the blisters and dead tissues, and after daily rinsing with normal saline, is exposed to air for 5 minutes to dry. Then, 1% silver sulfadiazine silver ointment is placed on the wound by a sterile abscess of 5 mm size. After 1 hour, without wound healing in the intervention group, a sterile abscess of 5 mm formulation Place the egg white on the wound and dressing.
Category
Treatment - Drugs

2

Description
Control group: The second degree otitis wounds remained completely intact and in the second grade wound, which was usually blotched, after removing the blisters and dead tissues, and after daily washing with normal saline, is exposed to air for 5 minutes to dry. Then, 1% silver silver sulfadiazine ointment is placed on the wound by a sterile abscess of 5 mm size, and after 1 hour, without wound wound in the control group, a sterile abscess of 5 mm We take the placebo on the wound and dressing.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
Full name of responsible person
hadis ashrafizadeh
Street address
2- Student Researches Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
City
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Dr behzad sharif makhmal zadeh
Full name of responsible person
hadis ashrafizadeh
Street address
Vice Chancellor for research of Ahvaz Jundishapur University of medical
City
Ahvaz Jundishapur University of medical sciences
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr behzad sharif makhmal zadeh
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
Full name of responsible person
hadis ashrafizadeh
Position
master sciences
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
City
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
Postal code
Phone
+216 133738255
Fax
Email
ashrafizadeh.h1993@gmail.comashrafizadeh.h@ajums.ac.irashrafizadeh.h@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
Full name of responsible person
simin jahani/ hadis ashrafizadeh
Position
phd/ master sciences
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
City
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
Postal code
Phone
00
Fax
Email
jahanisimin@yahoo.comashrafizadeh.h1993@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of medical sciences, Ahvaz, Iran.
Full name of responsible person
hadis ashrafizadeh
Position
master sciences
Other areas of specialty/work
Street address
2- Student Researches Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
City
University of Medical Sciences, Ahvaz, Iran.
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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