]>
IRCT20231019059765N1 IRCT 2023-12-30 CMH Lahore Medical College and Institute of Dentistry, Lahore, Pakistan How effective is tranexamic acid in controlling post-surgical drainage after neck dissection surgery in patients with the oral cancers Evaluating the Efficacy of Topical Tranexamic Acid in Neck Dissection to Reduce Post-Operative Drain Output: A Prospective Randomized Controlled Trial 2023-12-25 anticipated 44 Complete https://irct.ir/trial/74481 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method: Simple Randomization Unit: Individual Stratified randomization Computer randomization using software 2 parallel groups (control group and intervention group) Allocation will be concealed from the patient and principal investigator (assessor) but not from the primary surgeon (Double Blind), Blinding description: After taking patient consent, they'd be randomly sampled using computer software and handed a sealed envelope the receptionist. The patient shall be blind to whether he has been placed in intervention or control group. Patient will handover the sealed envelope to the surgeon and his team in Operation Theatre who won't be blind to the random sampling, they'd open the sealed envelope and as per serial number, would know if the patient is in intervention group or control group. The assessor won't be present in the OT operation theater and shall remain blind to sampling. Assessor will remain in ward where the patient shall be transferred and remain admitted after surgery, the assessor will analyze the data. Surgeon shall visit ward daily to ensure patients are stable. 4 Neck Drain output after Tumor Resection and Neck Dissection Surgery for Oral Cance3. Intervention 1: Intervention group having 22 randomly allocated subjects: After tumor resection and neck dissection (supraomohyoid) A total of 20 ml of Tranexamic Acid (TXA) topical solution will be prepared at a concentration of 25 mg/ml by adding one ampule (5 ml) of TXA (100 mg/ml) to 15 ml of normal saline. After achieving complete hemostasis, following supraomohyoid neck dissection for oral, head and neck cancers, 20 ml of TXA solution will be sprayed on the operated field in the neck, once.Dose: 20 ml of topical tranexamic acid at a dose of 25mg/ml (5ml ampule of tranexamic acid containing 100mg/ml of tranexamic acid, mixed with 15ml of normal saline).Mode: Topical (spray solution) Duration: Once before neck closure.There shall be NO repeated administration.Neck Drain Output shall be monitored hourly and once it is less than 25 ml in 24 hrs, drain shall be removed.After spraying the above-mentioned solution, closed suction drain shall be placed and neck closure shall be done in standard way by suturing it in 2 layers. Intervention 2: Control group: 22 randomly allocated subjects, they will NOT receive topical application of tranexamic acid, instead, after tumor resection and neck dissection, and after achieving hemostasis, neck shall be closed in 2 layers (subcutaneous and cutaneous sutures) after placing vacuum suction neck drain. No - There is not a plan to make this available Justification or reason for not sharing IPD is CMH Lahore doesn't allow sharing data of patients
public Muhammad Azhar Imran
House Address Flat 57-F, Second Floor, Askari 1, Sarfaraz Rafique Road, Lahore cantt
Lahore Cantonment Pakistan 54810 +92 321 4267505 azhar.imran1993@gmail.com CMH Lahore Medical College and Institute of Dentistry scientific Muhammad Azhar Imran
House Address Flat 57-F, Second Floor, Askari 1, Sarfaraz Rafique Road, Lahore cantt
Lahore Cantonment Pakistan 54810 +92 321 4267505 azhar.imran1993@gmail.com CMH Lahore Medical College and Institute of Dentistry Pakistan Patients 18 years of age or older Patients who will undergo supraomohyoid neck dissection due to oral, head and neck cancers. Patients who consent to be part of this study, who are willing and able to comply with the protocols of the study. 18 years no limit Both Patients who have a history of hypersensitivity or any adverse reaction to tranexamic acid or any of its components. Patients having thromboembolic events in the past or any related disorder like pulmonary embolism or DVT. Patients who have bleeding disorders. Patients having contraindications to TXA, such as renal failure/disease or active thromboembolic disease. Patients who are on anticoagulant or antiplatelet therapy that can not be stopped for this surgery. Patients who do not wish to provide informed consent and are unwilling to be part of the study. C14 Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx Treatment - Drugs N/A Intervention group having 22 randomly allocated subjects: After tumor resection and neck dissection (supraomohyoid) A total of 20 ml of Tranexamic Acid (TXA) topical solution will be prepared at a concentration of 25 mg/ml by adding one ampule (5 ml) of TXA (100 mg/ml) to 15 ml of normal saline. After achieving complete hemostasis, following supraomohyoid neck dissection for oral, head and neck cancers, 20 ml of TXA solution will be sprayed on the operated field in the neck, once.Dose: 20 ml of topical tranexamic acid at a dose of 25mg/ml (5ml ampule of tranexamic acid containing 100mg/ml of tranexamic acid, mixed with 15ml of normal saline).Mode: Topical (spray solution) Duration: Once before neck closure.There shall be NO repeated administration.Neck Drain Output shall be monitored hourly and once it is less than 25 ml in 24 hrs, drain shall be removed.After spraying the above-mentioned solution, closed suction drain shall be placed and neck closure shall be done in standard way by suturing it in 2 layers. Control group: 22 randomly allocated subjects, they will NOT receive topical application of tranexamic acid, instead, after tumor resection and neck dissection, and after achieving hemostasis, neck shall be closed in 2 layers (subcutaneous and cutaneous sutures) after placing vacuum suction neck drain. Post-operative drainage for the first 24 hrs., first 5 days and the day of removal of drain are the primary outcomes. Timepoint: First 24 hours following surgery, first 5 days, and day of removal of drain. Method of measurement: Measurements in milliliters on vacuum suction drain bottle. Whereas the secondary outcomes are surgical site infection (grade of infection), hematoma formation, flap necrosis for neck dissection complications. Timepoint: Day 1 to day 5 till drain removal. Method of measurement: Clinical Examination and visual analogue scale. CMH Lahore Medical College and Institute of Dentistry, Lahore, Pakistan Approved 2023-10-27 Ethical Review Committee, CMH Lahore Medical College and Institute of Dentistry CMH Lahore Medical College and Institute of Dentistry, Abdur Rehman Road, Lahore Cantt, Pakistan Lahore Punjab Pakistan