Investigation of the effect of bromelain supplementation on the healing of skin flaps applied after the resection of non-melanoma cancers in the head and neck region
The primary aim of this study is to determine the effect of bromelain on the healing of skin flaps after the resection of non-melanoma cancers in the head and neck region. The secondary objectives include: Comparing the effect of bromelain on the healing of skin flaps applied after the resection of non-melanoma cancers in the head and neck region based on the patient's age and gender, the location, the extent of macroscopic improvement and healing of skin flaps, prevention of necrosis, scar formation after surgery, aesthetic criteria and cosmetic satisfaction, pain severity and inflammation, incidence of surgical site infection, and potential side effects related to bromelain use.
Design
randomized, non-blinded due to unavailability of placebo, controlled clinical trial with a parallel group of 60 patients, and randomization was performed using a random number generator application.
Settings and conduct
Farhikhtegan Hospital in Tehran during the years 2024-2025.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
informed consent
pathology confirmation
indication for skin flap
Exclusion criteria:
diabetes
immunosuppressed
corticosteroid regimen
radiotherapy
melanoma diagnosis
anticoagulants consumption
incomplete follow up or missed information
Intervention groups
In the intervention group, an oral capsule branded as Anaheal 500 mg will be administered daily for 15 days. In the control group, routine wound dressing care will continue. The healing of skin flaps in both groups will be evaluated during a one-month follow-up period using standard criteria, including the rate of graft healing based on skin traction and the minimum number of days required for suture removal.
Main outcome variables
malignancy type; extent of lesion; rate of healing; pain and inflammation; surgical infection incidence; aesthetic; necrosis; adverse effects; groups (case and control)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240903062943N1
Registration date:2024-10-28, 1403/08/07
Registration timing:registered_while_recruiting
Last update:2024-10-28, 1403/08/07
Update count:2
Registration date
2024-10-28, 1403/08/07
Registrant information
Name
Amir Ehtemami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2640 0848
Email address
amir.ehtem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-26, 1403/08/05
Expected recruitment end date
2025-05-21, 1404/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of bromelain supplementation on the healing of skin flaps applied after the resection of non-melanoma cancers in the head and neck region
Public title
Investigation of the effect of bromelain supplementation on the healing of skin flaps
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
indication for skin flap after primary resection
pathology confirmation
informed consent to participate
Exclusion criteria:
malnutrition
diabetes
immunosuppressed
corticosteroids regimens
currently under radiotherapy
diagnosis of melanoma
warfarin administration (possible interaction with bromelain)
incomplete follow-up and missed information
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
We will use randomization to assign each patient to either the intervention or control group using the website random.org. If the generated number is odd, the patient will be placed in the intervention group and receive bromelain. If the number is even, the patient will be placed in the control group without receiving the drug.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, Islamic Azad University of Medical Sciences, Tehran
Street address
You’re right! The correct order for addressing in English would be: Administrative Building of Islamic Azad University of Medical Sciences, Tehran, Corner of Gole Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Gholhak Crossroad, Dr. Shariati Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.IAU.TMU.REC.1403.282
Health conditions studied
1
Description of health condition studied
non-melanoma cancers in the head and neck region
ICD-10 code
C44.4
ICD-10 code description
Other and unspecified malignant neoplasm of skin of scalp and neck
2
Description of health condition studied
surgical wound healing
ICD-10 code
ICD-10 code description
3
Description of health condition studied
skin flap
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
wound healing rate
Timepoint
at the beginning of study (before intervention) and from the second week, every other day
Method of measurement
minimum number of days required for suture removal based on skin traction
Secondary outcomes
1
Description
pain and inflammation severity
Timepoint
daily
Method of measurement
Visual Analogue Scale
2
Description
aesthetic and cosmetic satisfaction
Timepoint
at the end of follow-up
Method of measurement
Likert scale
3
Description
necrosis
Timepoint
at the beginning of study (before intervention) and from the second week, every other day
Method of measurement
clinical observation
4
Description
surgical site infection incidence
Timepoint
every other day
Method of measurement
clinical observation
5
Description
adverse effects of bromelains
Timepoint
every other day
Method of measurement
checklist
Intervention groups
1
Description
First intervention group: Capsule of bromelain 1500 mg is administered daily for 15 days.
Category
Treatment - Drugs
2
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhikhtegan hospital
Full name of responsible person
Ehsanollah Rahimi Movaghar
Street address
Shohadaye Hesarak Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
farhikhteganhospital@gmail.com
Web page address
https://tms.iau.ir/farhikhtegan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Masoud Parsania
Street address
You’re right! The correct order for addressing in English would be: Administrative Building of Islamic Azad University of Medical Sciences, Tehran, Corner of Gole Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Gholhak Crossroad, Dr. Shariati Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2264 0599
Email
masoud_parsania@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran Islamic Azad University, faculty of Medicine
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
Islamic Azad University
Full name of responsible person
Amir Ehtemami
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 19, First alley, North Naft Ave., Mirdamad Blvd.,
City
Tehran
Province
Tehran
Postal code
1919634481
Phone
+98 21 2640 0848
Email
amir.ehtem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsanollah Rahimi Movaghar
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Farhangian Hospital, University Square, End of North Sattari, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4484 5163
Email
ehsanrm81@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Ehtemami
Position
medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 19, First alley, North Naft Ave., Mirdamad Blvd.,
City
Tehran
Province
Tehran
Postal code
1919634481
Phone
+98 21 2640 0848
Email
amir.ehtem@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data related to the study objectives can be shared after being de-identified.
When the data will become available and for how long
Access will begin at April 2025 and continue for 6 months after the publication of the results.
To whom data/document is available
Academic and scientific researchers
Under which criteria data/document could be used
Researchers in related fields such as surgery, wound care, cancer, and herbal medicines
Review article researchers
From where data/document is obtainable
Amir Ehtemami: amir.ehtem@gmail.com
Dr. Ehsanollah Rahimi Movaghar: ehsanrm81@gmail.com
What processes are involved for a request to access data/document
Emails sent to the provided addresses will be responded to as soon as possible.