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IRCT20240903062943N1 IRCT 2024-10-28 Islamic Azad University Investigation of the effect of bromelain supplementation on the healing of skin flaps 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 2024-10-29 anticipated 60 Complete https://irct.ir/trial/79056 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: 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. 2-3 Condition 1: non-melanoma cancers in the head and neck region. Condition 2: surgical wound healing. Condition 3: skin flap. Intervention 1: First intervention group: Capsule of bromelain 1500 mg is administered daily for 15 days. Intervention 2: Control group: no intervention. Yes - There is a plan to make this available What will be shared: The data related to the study objectives can be shared after being de-identified. When: Access will begin at April 2025 and continue for 6 months after the publication of the results. To whom: Academic and scientific researchers Conditions: Researchers in related fields such as surgery, wound care, cancer, and herbal medicines Review article researchers Where to obtain: Amir Ehtemami: amir.ehtem@gmail.com Dr. Ehsanollah Rahimi Movaghar: ehsanrm81@gmail.com How to obtain: Emails sent to the provided addresses will be responded to as soon as possible. Comments:
public Amir Ehtemami
No 19, First alley, North Naft Ave., Mirdamad Blvd.,
Tehran Iran (Islamic Republic of) 1919634481 +98 21 2640 0848 amir.ehtem@gmail.com Islamic Azad University scientific Ehsanollah Rahimi Movaghar
Farhangian Hospital, University Square, End of North Sattari, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1477899679 +98 21 4484 5163 ehsanrm81@gmail.com Islamic Azad University Iran (Islamic Republic of) indication for skin flap after primary resection pathology confirmation informed consent to participate no limit no limit Both malnutrition diabetes immunosuppressed corticosteroids regimens currently under radiotherapy diagnosis of melanoma warfarin administration (possible interaction with bromelain) incomplete follow-up and missed information C44.4 Other and unspecified malignant neoplasm of skin of scalp and neck Treatment - Drugs N/A First intervention group: Capsule of bromelain 1500 mg is administered daily for 15 days. Control group: no intervention 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. Pain and inflammation severity. Timepoint: daily. Method of measurement: Visual Analogue Scale. Aesthetic and cosmetic satisfaction. Timepoint: at the end of follow-up. Method of measurement: Likert scale. Necrosis. Timepoint: at the beginning of study (before intervention) and from the second week, every other day. Method of measurement: clinical observation. Surgical site infection incidence. Timepoint: every other day. Method of measurement: clinical observation. Adverse effects of bromelains. Timepoint: every other day. Method of measurement: checklist. Tehran Islamic Azad University, faculty of Medicine Approved 2024-05-11 Ethics Committee of the Faculty of Medicine, Islamic Azad University of Medical Sciences, Tehran 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. Tehran Tehran Iran (Islamic Republic of)