1. Home
  2. Approved trials
  3. » فارسی

A comparative study of the effects of Hypericum Perforatum and Dexpanthenol topical cream on the healing process of scar caused by neck surgeries

Protocol summary

Study aim
A comparative study of the effect of Hypericum Perforatum and Dexpanthenol topical cream on the healing process of scar caused by neck surgeries
Design
This a controlled, paralleled, double-blind, randomized, clinical trial on 48 patients. Randomization was done with SAS software version 9.
Settings and conduct
The study will be conducted in Amir al-Mominin Hospital in Rasht. The study will be conducted in two groups of intervention and control. The participant and the researcher will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Neck surgery After suture removal Obtaining informed consent Exclusion criteria: Previous sensitivity to products containing Hypericum Perforatom Receiving other drugs effective on wound healing Suffering from diseases that interfere with wound healing (chronic systemic diseases of the heart, kidney, lung, coagulation disorder, immune deficiency, connective tissue disorder, diabetes, anemia, hemophilia, and malnutrition) Having a history of previous injury or surgery and visible lesions in the neck area
Intervention groups
After surgery and suture removal, the first group receives Hypericum Perforatom topical cream 3 times a day and the second group receives Dexpanthenol cream 3 times a day for three months. During three months, the patients will be visited weekly and the healing process of the wound will be measured.
Main outcome variables
In order to evaluate the healing process of the wound in this study, the SCAR scale was used: scar spread; erythema; dyspigmentation (includes hyperpigmentation and hypopigmentation); track marks or suture marks; hypertrophy/atrophy; overall impression and the patient's pain and itching are the measured variables.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220516054879N6
Registration date: 2023-07-03, 1402/04/12
Registration timing: registered_while_recruiting

Last update: 2023-07-03, 1402/04/12
Update count: 0
Registration date
2023-07-03, 1402/04/12
Registrant information
Name
maryam shahrokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9026
Email address
mshahrokhi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-03, 1402/03/13
Expected recruitment end date
2023-10-05, 1402/07/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of Hypericum Perforatum and Dexpanthenol topical cream on the healing process of scar caused by neck surgeries
Public title
The effects of Hypericum Perforatum and Dexpanthenol topical cream on the healing process of scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with neck wounds caused by surgery After removing the stitches obtaining informed consent
Exclusion criteria:
Previous sensitivity to products containing Hypericum Perforatom Receiving other drugs effective on wound healing Suffering from diseases that interfere with wound healing (chronic systemic diseases of the heart, kidney, lung, coagulation disorder, immune deficiency, connective tissue disorder, diabetes, anemia, hemophilia, and malnutrition) Having a history of previous injury or surgery and visible lesions in the neck area
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
The 4 permutation block randomization method was used to randomize patients into two groups. Given that Group A is the intervention group and Group B is the control group. Randomization was done with SAS software version 9. For allocation concealment, opaque-sealed envelopes will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. Comparison of color and smell between Hypericum and Dexpanthenol creams will be done using allowed color and essential oil. The type of treatment will be placed inside a sealed envelope and delivered to the nurse and statistical analyst. The researcher and the participant will be blind.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Deputy of research and technology, In front of 17 shahrivar hospital, Shaid siadati street,Namjoo street, Rasht
City
Rasht
Province
Guilan
Postal code
4193713111
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
IR.GUMS.REC.1402.058

Health conditions studied

1

Description of health condition studied
Scar caused by neck surgery
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin

Primary outcomes

1

Description
Scar spread
Timepoint
Scar spread will be measured at the beginning of the study and then weekly for 3 months.
Method of measurement
Based on the observation of the researcher

2

Description
Erythema
Timepoint
Erythema will be measured at the beginning of the study and then weekly for 3 months.
Method of measurement
Based on the observation of the researcher

3

Description
Dyspigmentation
Timepoint
Dyspigmentation will be measured at the beginning of the study and then weekly for 3 months.
Method of measurement
Based on the observation of the researcher

4

Description
Track marks or suture marks
Timepoint
Track marks or suture marks will be measured at the beginning of the study and then weekly for 3 months.
Method of measurement
Based on the observation of the researcher

5

Description
Hypertrophy/atrophy
Timepoint
Hypertrophy/atrophy will be measured at the beginning of the study and then weekly for 3 months.
Method of measurement
Based on the observation of the researcher

6

Description
Overall impression
Timepoint
Overall impression will be measured at the beginning of the study and then weekly for 3 months.
Method of measurement
Based on the observation of the researcher

7

Description
Pain
Timepoint
Pain will be measured at the beginning of the study and then weekly for 3 months.
Method of measurement
Based on questions from the patient

8

Description
Itch
Timepoint
Itch will be measured at the beginning of the study and then weekly for 3 months.
Method of measurement
Based on questions from the patient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receiving 3 times a day topical cream formulation of Hypericum perforatum plant with 70% ethanolic extract with 2% concentration of total extract for 3 months.
Category
Treatment - Drugs

2

Description
Control group: Receiving 3 times a day Dexpanthenol 5% topical cream from Raha Pharmaceutical Company for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir al-Momenin Hospital
Full name of responsible person
Ali Faghih Habibi
Street address
Amir- al Momenin Educational Remedial & Research Center,17th Shahrivar Street, Dr. Heshmat Square, Imam Khomeini Street
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3323 8307
Fax
Email
amiralmomenin@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
In front of 17 shahrivar Hospital, Shahid Siadati Street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Maryam Shahrokhi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
17shahrivar Hospital, Shahid Siadati Street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
414465379
Phone
+98 13 3336 9019
Email
shahrokhi.mail85@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Maryam Shahrokhi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
17shahrivar Hospital, Shahid Siadati Street, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9019
Email
shahrokhi.mail85@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Fatemeh Naghibi
Position
Pharmacy Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 4, No.1174, Yousefi Alley, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144664145
Phone
+98 911 865 1643
Email
fatemeh.naghibi77@gmail.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
Patient privacy and ethical principles
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
No - There is not 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
The results of the study will be available to everyone, specific information will be available only to the treatment staff. To protect the patient's privacy, the patient's information will be protected by the researcher.
When the data will become available and for how long
There is currently no plan to publish the data, but if published, it will be 6 months after the results are published.
To whom data/document is available
Researchers working in this field, Otolaryngologists and scientists with qualifications
Under which criteria data/document could be used
Physicians and researchers will have the right to request, there are restrictions on patient privacy and medical ethics
From where data/document is obtainable
Dr. Maryam Shahrokhi, 17 Shahrivar Hospital, Rasht; Fatemeh Naghibi, School of Pharmacy guilan university of meical science
What processes are involved for a request to access data/document
Refer to the 17 Shahrivar Hospital in Rasht and sign the application form, then meet with the project researcher and review the client's request - consult with the Medical Ethics Committee, then provide documentation
Comments
Loading...