Protocol summary
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Study aim
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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.
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Design
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randomized, single-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.
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Settings and conduct
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Farhikhtegan Hospital in Tehran during the years 2024-2025.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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In the intervention group, an oral capsule branded as Anaheal 500 mg will be administered 3 times a day 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.
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Main outcome variables
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malignancy type; extent of lesion; rate of healing; pain and inflammation; surgical infection incidence; aesthetic; necrosis; adverse effects; groups (case and control)
General information
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Reason for update
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We performed recruitment of this prospective study after registration, as emphasized in other sections. There was a misstatement of “Actual recruitment start date” that resulted in the incorrect speculation. Hence, we revised the aforementioned matter accordingly.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240903062943N1
Registration date:
2024-10-28, 1403/08/07
Registration timing:
prospective
Last update:
2026-04-26, 1405/02/06
Update count:
2
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Registration date
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2024-10-28, 1403/08/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-10-29, 1403/08/08
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Expected recruitment end date
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2025-07-22, 1404/04/31
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Actual recruitment start date
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2024-11-29, 1403/09/09
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Actual recruitment end date
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2025-09-22, 1404/06/31
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Trial completion date
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2025-09-22, 1404/06/31
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Scientific title
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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
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Public title
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Investigation of the effect of bromelain supplementation on the healing of skin flaps
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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An independent collaborator (who was not involved in surgery, postoperative assessment, or suture removal) performed randomization and allication, which was concealed from the surgical and follow-up teams. However, participants were not blinded due to lack of placebo.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-05-11, 1403/02/22
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Ethics committee reference number
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IR.IAU.TMU.REC.1403.282
Health conditions studied
1
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Description of health condition studied
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non-melanoma cancers in the head and neck region
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ICD-10 code
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C44.4
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ICD-10 code description
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Other and unspecified malignant neoplasm of skin of scalp and neck
2
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Description of health condition studied
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surgical wound healing
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ICD-10 code
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ICD-10 code description
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3
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Description of health condition studied
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skin flap
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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wound healing rate
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Timepoint
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at the beginning of study (before intervention) and from the second week, every other day
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Method of measurement
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minimum number of days required for suture removal based on skin traction
Secondary outcomes
1
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Description
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pain and inflammation severity
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Timepoint
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daily
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Method of measurement
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Visual Analogue Scale
2
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Description
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aesthetic and cosmetic satisfaction
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Timepoint
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at the end of follow-up
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Method of measurement
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Likert scale
3
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Description
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necrosis
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Timepoint
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at the beginning of study (before intervention) and from the second week, every other day
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Method of measurement
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clinical observation
4
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Description
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surgical site infection incidence
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Timepoint
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every other day
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Method of measurement
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clinical observation
5
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Description
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adverse effects of bromelains
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Timepoint
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every other day
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Method of measurement
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checklist
Intervention groups
1
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Description
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First intervention group: Capsule of bromelain 1500 mg is administered daily for 15 days.
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Category
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Treatment - Drugs
2
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Description
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Control group: no intervention
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Tehran Islamic Azad University, faculty of Medicine
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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The data related to the study objectives can be shared after being de-identified.
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When the data will become available and for how long
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Access will begin at April 2025 and continue for 6 months after the publication of the results.
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To whom data/document is available
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Academic and scientific researchers
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Under which criteria data/document could be used
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Researchers in related fields such as surgery, wound care, cancer, and herbal medicines
Review article researchers
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From where data/document is obtainable
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Amir Ehtemami: amir.ehtem@gmail.com
Dr. Ehsanollah Rahimi Movaghar: ehsanrm81@gmail.com
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What processes are involved for a request to access data/document
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Emails sent to the provided addresses will be responded to as soon as possible.
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Comments
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