Determining the effectiveness of bromelain versus placebo on oedema and ecchymosis after rhinoplasty surgery on days 1, 3, 7 and 11
Design
In this double-blind clinical trial, Two-group randomization on the web ( www.graphpad.com ) created a simple random sequence. The Otolaryngologist who completed the questionnaire, the patients, and the statistical analysis were all blinded to the content of capsules and the patients’ group(Double-blind). The sample size was equal to 23 people in each group.
Settings and conduct
Patients who undergo rhinoplasty surgery in the otolaryngology operating room of Amirkabir Arak hospital and after the operation refer to the otolaryngology clinic.
The study is double blind. Blinding of the analyst and completing the questionnaire and the statistical analyst (double blind) is done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People over 18 to 60 who have undergone open rhinoplasty surgery; People who must have a lateral osteotomy in their surgery; Not using dexamethasone during and after surgery; Not using a cold compress after surgery; Absence of vascular diseases and coagulation disorders; History of allergy to Bromelain or any of the product's components
Intervention groups
23 people will be given a 200 mg bromelain capsule equivalent to 500 GDU every 8 hours and a placebo capsule containing starch.
Main outcome variables
The amount of edema and ecchymosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180519039720N2
Registration date:2024-07-13, 1403/04/23
Registration timing:retrospective
Last update:2024-07-13, 1403/04/23
Update count:0
Registration date
2024-07-13, 1403/04/23
Registrant information
Name
Benyamin Rahmaty
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 3352
Email address
b-rahmaty@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-03-15, 1402/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of bromelain on the amount of edema and ecchymosis after rhinoplasty versus placebo
Public title
The effectiveness of bromelain on the amount of edema and ecchymosis after rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who must have a lateral osteotomy in their surgery
Not using dexamethasone during and after surgery
Not using a cold compress after surgery.
Absence of vascular disease
Absence of coagulation disorders
History of allergy to Bromelain or any of the pineapple products
Exclusion criteria:
Withdrawal from the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
To create a simple random sequence, two-group randomization on the web (www.graphpad.com) will be used, and to hide the random allocation, the packet envelope method with random sequence (SNOSE) will be used. Several envelopes are prepared. Each of the created random sequences is recorded on a card. The cards are placed in the letter envelopes in order. To preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in the boxes in order. Then, according to the order of entry of the eligible participants into the study, one of the letter envelopes is opened, and the assigned group of that participant is A or B.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is Double blind. Blinding of the analyst and completing the questionnaire and the statistical analyst (Double blind) is done. The analyzer and the outcome evaluator are not aware of the grouping. The outcome evaluator does not know about group types. The groups in the form of A and B are given to the analyzer and the outcome evaluator.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Arak University of Medical Sciences
Street address
Shahid Shiroodi Street
City
Arak
Province
Markazi
Postal code
3848170001
Approval date
2022-11-20, 1401/08/29
Ethics committee reference number
IR.ARAKMU.REC.1401.243
Health conditions studied
1
Description of health condition studied
Nose deformity
ICD-10 code
M95.0
ICD-10 code description
Acquired deformity of nose
Primary outcomes
1
Description
Edema and Ecchymosis scoring after Rhinoplasty
Timepoint
At 1, 3, 7, 11 days after surgery
Method of measurement
Visual scoring
Secondary outcomes
empty
Intervention groups
1
Description
In this Double -blind clinical trial, participants from 18 to 39 years of age who were scheduled for open preservation rhinoplasty and lateral osteotomy as one of the planning procedures in their surgery were recruited. Participants must not take any anti-inflammatory drug or steroid during or after the surgery, and cold compresses after surgery were also not used. Other exclusion criteria included the absence of high blood pressure and coagulation disorders and any history of allergy to Bromelain or pineapple products. We did not prescribe any painkillers to either group; we only prescribed acetaminophen 500 mg every 6 hours to both groups. After obtaining informed consent, the inclusion and exclusion criteria were reviewed; then, all participants underwent open preservation rhinoplasty and lateral osteotomy during the surgery. After the procedure, a group of 23 people was randomly assigned to Bromelain 200 mg capsules (equivalent to 500 GDU) every 8 hours.
Category
Treatment - Drugs
2
Description
The placebo group received starch-filled capsules, similar in appearance, every 8 hours.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Benyamin Rahmaty
Street address
Amirkabir hospital, Parastar SQ, Shiroudi St, Arak, Markazi, Iran
City
Arak
Province
Markazi
Postal code
38196 91187
Phone
+98 912 334 0587
Email
Benyamin.Rahmaty@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davoud Hekmatpour
Street address
Vice Chancellor for Research and Technology Arak University of Medical Sciences Payambar Azam University Complex Basij Square Arak Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3383 8319
Email
dr_hekmat@arakmu.ac.ir
Grant name
Davoud Hekmatpour, Vice President of Research and Technology
Grant code / Reference number
4191
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Benyamin Rahmaty
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Plate number:6 , Mir Eshghi Alley, Shiroudi(Khorram) St, Arak, Markazi, Iran
City
Arak
Province
Markazi
Postal code
3813895397
Phone
+98 912 334 0587
Email
Benyamin.Rahmaty@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Benyamin Rahmaty
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Department of Otorhinolaryngology - Head and Neck Surgery, Alamolhoda, Arak Medical University of Medical Sciences, Arak, Iran
City
Arak
Province
Markazi
Postal code
A'lam-Al-Hoda Street
Phone
0098864021631
Email
Benyamin.Rahmaty@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Benyamin Rahmaty
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Department of Otorhinolaryngology - Head and Neck Surgery, Alamolhoda, Arak Medical University of Medical Sciences, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848170001
Phone
0098864021631
Email
Benyamin.Rahmaty@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
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts six months after the results are published.
To whom data/document is available
It will be available for researchers working in academic and scientific institutions, or people working in industry can apply for them.
Under which criteria data/document could be used
People who officially send their application through academic email or letter must have an educational background.
From where data/document is obtainable
They will be available after you contact the mentioned email or phone numbers, including 00989123340597 or the existing email, Benyamin.rahmaty@gmail.com.
What processes are involved for a request to access data/document
After checking the requested information, it will be available for at least one month.