Investigating the effect of chitosan/aloe vera gel loaded with zinc oxide nanoparticles in treatment of wounds after gynecological surgeries: a randomized clinical trial
Evaluation of the regenerative effects of chitosan/aloe vera gel loaded with zinc nano particles in the treatment of wounds after gynecological surgeries.
Design
In this study, after obtaining informed consent from the volunteers, 66 patients were divided into two groups of 33 people, including the group receiving chitosan aloe vera zinc oxide gel and the placebo group receiving carbomer gel. After at least 72 hours of surgery, each of the patients uses chitosan aloe vera zinc oxide gel or placebo gel twice a day for one month. The wound healing process in the studied patients will be checked by the attending physician at the end of the first and fourth week according to the wound evaluation checklist.
Settings and conduct
This study will be conducted in two different hospitals located in Tehran and Golestan in a double-blind manner. None of the patients or doctors are aware of the type of medicine received.
Participants/Inclusion and exclusion criteria
All pregnant women over the age of 15 who have had 72 hours of caesarean section or women's surgeries and are unable to breastfeed (including hysterectomy (uterus removal) or ovarian cysts, etc.) .
Intervention groups
The first group receiving aloe vera chitosan gel loaded with zinc oxide nanoparticles
The second group received carbomer gel as a placebo
Main outcome variables
Improvement in Patient and Observer Scar Assessment Scale (POSAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230629058615N2
Registration date:2024-05-08, 1403/02/19
Registration timing:prospective
Last update:2024-05-08, 1403/02/19
Update count:0
Registration date
2024-05-08, 1403/02/19
Registrant information
Name
Amir Rezazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 729 8761
Email address
rezazadeh.am@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of chitosan/aloe vera gel loaded with zinc oxide nanoparticles in treatment of wounds after gynecological surgeries: a randomized clinical trial
Public title
the effect of chitosan/aloe vera gel loaded with zinc oxide nanoparticles in treatment of wounds after gynecological surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women who have undergone any gynecological surgery (including surgery related to ovarian cysts, hysterectomy, etc.) or cesarean section and 72 hours have passed since their operation.
Women diagnosed with postoperative surgical wounds
Women who are able to understand and comply with the study procedures and follow-up requirements
Women who are 15 years of age or older
Mothers unable or unwilling to breastfeed their infants
Exclusion criteria:
Being allergic to any of chitosan, aloe vera and zinc oxide nanoparticles
Patients with severe renal failure (GFR less than 30)
Patients with severe liver failure (Child Pugh score B-C)
Taking certain drugs (such as glucocorticoids, anticoagulants, immunosuppressants) while using the study gel
Women who are able and willing to breastfeed.
Age
From 15 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, volunteers were individually assigned to two drug and placebo groups using block randomization. It should be noted that 4 sized blocks are used in this method.
Block randomization was done using the "https://www.sealedenvelope.com/simple-randomiser/v1/lists" website and the obtained specialized codes (including two English letters and one number) were assigned to each candidate in the order of entry.
Blinding (investigator's opinion)
Double blinded
Blinding description
Block randomization was performed by an independent person and based on the obtained codes, drugs and placebo were numbered. Doctors and study administrators only deliver medicine or placebo to patients based on each person's code and do not know the type of medicine. The patients also received the medicine only with the specified code and are not aware of the type of treatment. It should be mentioned that the statistical analyst was also unaware of the type of groups and only based on the information received from the mentioned independent person, he considered the patients in two groups and used statistical tests.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committees of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, 1449614535, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-11-15, 1402/08/24
Ethics committee reference number
IR.IUMS.REC.1402.728
Health conditions studied
1
Description of health condition studied
wounds after gynecological surgeries (such as caesarean section, hysterectomy, etc.)
ICD-10 code
O90.0
ICD-10 code description
Disruption of cesarean delivery wound
Primary outcomes
1
Description
enhancement of wound condition
Timepoint
End of week 1 and week 4
Method of measurement
Measurement by "Patient and Observer Scar Evaluation Scale" score
Secondary outcomes
1
Description
Examining the inflammatory process and tissue healing
Timepoint
End of week 1 and week 4
Method of measurement
Evaluation of five healing factors including redness, edema, ecchymosis, secretion, and overlap of wound edges
Intervention groups
1
Description
Intervention group: People receiving Chitosan Aloe Vera Zinc Oxide Gel. After entering the study, 33 patients with post-surgical wounds were randomly assigned to the Treatment group based on the predetermined inclusion criteria. 72 hours after the operation, the formulation (gel containing Chitosan/Aloe Vera ZnO NP Gel) is used twice a day for one month. The intended formulation was prepared in the Pharmaceuticals and Nanotechnology Laboratory of the Faculty of Pharmacy, Iran University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: People receiving placebo. After entering the study, 33 patients with post-surgical wounds were randomly assigned to the placebo group based on the predetermined inclusion criteria. 72 hours after the operation, the formulation (gel containing carbomer) is used twice a day for one month. The intended formulation was prepared in the Pharmaceuticals and Nanotechnology Laboratory of the Faculty of Pharmacy, Iran University of Medical Sciences.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Madaran hospital
Full name of responsible person
Shahrooz Abdolmaleki
Street address
Aria Vatani Aley, Shahid Beheshti ST, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1577814311
Phone
+98 21 8875 1414
Email
info@madaran-hospital.com
2
Recruitment center
Name of recruitment center
Alejalil Hospital
Full name of responsible person
ّFedra Freidooni
Street address
Aq Qala, Golestan, Iran
City
Aq Qala
Province
Golestan
Postal code
4931813946
Phone
+98 17 3453 5766
Email
aghalahospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zohreh Mohammadi
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2030
Fax
Email
kamyab.dr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Sahand Soudi
Position
Non-academic pharmacist
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Iran University of Medical Sciences, Shahid Basarti St., Shahid Kabiri Tameh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۷۵۸۸۶۶۷۱
Phone
+98 21 4460 6181
Email
sahandsoudi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Rezazadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Shahid Basa'ati St., Shahid Kabiri Tamam (Shahin Shomali) St., Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۷۵۸۸۶۶۷۱
Phone
+98 912 729 8761
Fax
Email
rezazadeh.am@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kamyab Andarzbakhsh
Position
Clinical cooperator of the study
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Tehran, Gholhak, Dr. Shariati St., Yakhchal St., School of Pharmacy
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
Kamyab.dr@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
The final results of scoring the condition of the wound and related parameters
When the data will become available and for how long
After publishing the related article in international journals
To whom data/document is available
Researchers in the field of medicine and pharmacy
Under which criteria data/document could be used
Development of science and expand evidence related to treatment in further research
From where data/document is obtainable
Related journal
What processes are involved for a request to access data/document
Using the journal email to communicate and register a request to use the study data