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Comparative study of combined the effect of Cucurbita pepo L. oil and 1% silver sulfadiazine ointment with the control group on wound healing and severity of second degree burn pain in children 2-7 years

Protocol summary

Study aim
Determining the combined the effect of Cucurbita pepo L. oil and 1% silver sulfadiazine ointment with the control group on wound healing and severity of second degree burn pain in children 2-7 years
Design
The current research is a clinical trial study with a control group, with parallel groups, double-blind, random allocation, phase 3 on 98 eligible patients, who will be divided into two intervention and control groups using the random allocation (block) method.
Settings and conduct
This research is conducted on eligible children aged 2-7 years with second degree burns hospitalized in the burn department of Ayatollah Kashani Educational-Treatment Center, Shahrekord University of Medical Sciences, in compliance with all ethical conditions. Before the intervention, questionnaires are completed by all samples. In the intervention group, for the preparation of pumpkin seed oil, prepared Cucurbita pepo L. oil from Zardband company will be used, which is consistent with the mentioned study method and approved by the Ministry of Health. For the control group, 1% silver sulfadiazine ointment will be provided from the reputable Sina Daru company in the form of 50 gram tubes. In this study, patients, researchers, nurses and the person responsible for the analysis will not know the type of intervention for each person or group.
Participants/Inclusion and exclusion criteria
Children with second degree burns, 2 to 7 years old
Intervention groups
The studied patients are bandaged with pumpkin seed oil and silver sulfadiazine 1% once a day for a period of 14 days. The experimental group is treated with Cucurbita pepo L. oil and the control group is treated only with 1% silver sulfadiazine.
Main outcome variables
Face, Legs, Activity, Cry, Consolability scale is used to evaluate pain and Bates-Jensen Wound Assessment Tool is used to evaluate degeneration or healing of burn wounds.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190120042436N5
Registration date: 2023-01-29, 1401/11/09
Registration timing: prospective

Last update: 2023-01-29, 1401/11/09
Update count: 0
Registration date
2023-01-29, 1401/11/09
Registrant information
Name
Mohsen Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 4115
Email address
salarimo@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of combined the effect of Cucurbita pepo L. oil and 1% silver sulfadiazine ointment with the control group on wound healing and severity of second degree burn pain in children 2-7 years
Public title
Comparative study of combined the effect of Cucurbita pepo L. oil and 1% silver sulfadiazine ointment on wound healing and severity of second degree burn pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The cause of thermal burns Consent to participate in the study Age 2 to 7 years Second degree burn and below 20% and thermal type Burns in the hands and feet except the fingers Do not wash excessively with water and detergents Not having diseases that weaken the immune system The child's face is healthy and does not suffer from any congenital malformation, especially in the organs and face, and does not have trauma in the organs
Exclusion criteria:
Lack of parental consent Creating an active infection at the site of the lesion Use of topical immunosuppressants within four weeks before starting treatment Local infection Any vascular disease of the brain, cardiovascular Patients needing a skin graft for treatment
Age
From 2 years old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 98
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible children are selected through non-probability (available) sampling, but they are assigned to one of the two groups of intervention exercises and the control group in the form of random block allocation. The random allocation of blocks will be in such a way that according to the number of studied groups, which consists of two groups consisting of group 1 (intervention) and group 2 (control), the number of blocks will be calculated based on the factorial law, that is, 2 = 1 * 2 = 2! . The possible arrangement modes of the participants from each group in each block are indicated by the label A representing group 1 (intervention), B representing group 2 (control). Therefore, there are 2 blocks for random allocation, where there are 2 participants in each block, one person from each group, but their order is different. Block sampling will continue until the number of samples is completed. It should be noted that since there are 2 samples in each block, the number of selected samples will be the same in both groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients are informed that they may be placed in one of the intervention or control groups, and naturally they will receive the medicine related to the same group. In addition, the main researcher and the nurse who is responsible for the care of the patients, the person responsible for collecting the data and those who evaluate the outcome and the person responsible for the analysis will not know the type of intervention for each person or group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Yasuj University of Medical Science
Street address
Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad Province
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2023-01-04, 1401/10/14
Ethics committee reference number
IR.YUMS.REC.1401.161

Health conditions studied

1

Description of health condition studied
Burn of second degree
ICD-10 code
T30.2
ICD-10 code description
Burn of second degree, body region unspecified

Primary outcomes

1

Description
Wound healing score of Bates-Jensen Wound Assessment Tool
Timepoint
The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of repair and the fourteenth day after the start of treatment
Method of measurement
Bates-Jensen Wound Assessment Tool for healing of burn

2

Description
pain severity
Timepoint
The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of repair and the fourteenth day after the start of treatment
Method of measurement
Face, Legs, Activity, Cry, Consolability scale (FLACC scale)

Secondary outcomes

1

Description
pain degeneration
Timepoint
The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of repair and the fourteenth day after the start of treatment
Method of measurement
Bates-Jensen Wound Assessment Tool

Intervention groups

1

Description
Intervention group: The studied patients are dressed with pumpkin seed oil by the researcher once a day for a period of 14 days. The experimental group is treated with pumpkin seed oil. In this way, after washing the wounds daily with normal saline, in second-degree superficial wounds that usually have a complete blister, without removing the blister in the experimental group, a layer of pumpkin seed oil with a diameter of 5 mm will be placed on the wound and It is a dressing. In a second degree deep wound where the blisters are usually destroyed, after removing the blisters and dead tissues and washing the wound surface with normal saline in a sterile way and placing a layer of pumpkin seed oil with a diameter of 5 mm on the wound, a bandage is applied. be made patients in six stages; The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of recovery and the fourteenth day after the start of treatment are evaluated, and the day of the clear start of epithelization and the start of the repair process will be recorded for each patient. To check the condition of the wound, they are evaluated during the study and every time the dressing is changed. If any of the samples stop participating in the research for some reason, they will be removed and other samples will be selected and replaced in their place. Also, the condition of the wound is checked for the presence of granulation tissue and epithelization every time the dressing is changed. If signs of infection are observed, the sample will be removed from the study and referred to the doctor for further treatment. In order to increase the accuracy and accuracy of the research, two observers (the researcher and the permanent nurse who changes the dressing) will be used before the study and compared in the observed position. In addition, in each session, with the consent of the patient, photographs are taken of the lesions and they are examined in terms of the healing process. In this study, patients, caregivers, researchers and the person responsible for the analysis will not know the type of intervention for each person or group.
Category
Treatment - Drugs

2

Description
Control group: The studied patients were dressed with 1% silver sulfadiazine by the researcher once a day for a period of 14 days. The control group is treated only with 1% silver sulfadiazine. In this way, after washing the wounds daily with normal saline, in second-degree superficial wounds that usually have a complete blister, without removing the blister in the control group, a layer of 1% silver sulfadiazine cream with a diameter of 5 mm will be placed on the wound. And it is bandaged. In a second degree deep wound where the blisters are usually destroyed, after removing the blisters and dead tissues and washing the wound surface with normal saline in a sterile way and placing a layer of pumpkin seed oil with a diameter of 5 mm on the wound, a bandage is applied. be made patients in six stages; The first session before the start of treatment, the third day, the seventh day and the day of the clear start of epithelization, the day of recovery and the fourteenth day after the start of treatment are evaluated, and the day of the clear start of epithelization and the start of the repair process will be recorded for each patient. To check the condition of the wound, they are evaluated during the study and every time the dressing is changed. If any of the samples stop participating in the research for some reason, they will be removed and other samples will be selected and replaced in their place. Also, the condition of the wound is checked for the presence of granulation tissue and epithelization every time the dressing is changed. If signs of infection are observed, the sample will be removed from the study and referred to the doctor for further treatment. In order to increase the accuracy and accuracy of the research, two observers (researcher and a permanent nurse changing the dressing) will be checked and compared before the study, in the observed position. In addition, in each session, with the consent of the patient, photographs are taken of the lesions and they are examined in terms of the healing process. In this study, patients, researchers, nurses and the person responsible for the analysis will not know the type of intervention for each person or group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani hospital
Full name of responsible person
Maede Barati
Street address
Nurse Street., Ayatollah Kashani Hospital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۶۷۵۸۹۱۵
Phone
+98 38 3226 4825
Email
m.barati7788@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad Province
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7230
Email
m.barati7788@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Mohsen Salari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Yasuj, next to Imam Sajjad Hospital,Educational Campus, nursing Faculty
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591755418
Phone
+98 74 3323 4115
Fax
+98 74 3323 4115
Email
salarimo@yahoo.com
Web page address
https://scholar.google.com/citations?user=_-YWhDEAAAAJ&hl=fa&oi=ao

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hosein Sadeghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Yasuj, next to Imam Sajjad Hospital, Educational Campus - Faculty of Medicine
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591755418
Phone
+98 74 3323 0290
Fax
+98 74 3323 0290
Email
doctor.sadeghi@gmail.com
Web page address
https://scholar.google.com/citations?hl=fa&user=JiyQ8OIAAAAJ

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Maedeh Barati
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Jalil St., Yasouj University of Medical Sciences, Faculty of Nursing
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591755418
Phone
+98 74 3323 4115
Email
m.barati7788@gmail.com

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
Part of the data related to the main outcome will be shared
When the data will become available and for how long
Access to data six months after completion of collection and results
To whom data/document is available
Access to data through academic institutions
Under which criteria data/document could be used
Research works and references
From where data/document is obtainable
Yasuj University of Medical Science, Faculty of Nursing
What processes are involved for a request to access data/document
Access after going through the relevant administrative procedures
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