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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231019059765N1
Enrollment
44
Registered
2023-12-30
Start date
2023-12-25
Completion date
Unknown
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Drain output after Tumor Resection and Neck Dissection Surgery for Oral Cance3. Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx

Interventions

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 p

Sponsors

CMH Lahore Medical College and Institute of Dentistry, Lahore, Pakistan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Pakistan

Contacts

Public ContactMuhammad Azhar Imran

CMH Lahore Medical College and Institute of Dentistry

azhar.imran1993@gmail.com+92 321 4267505

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026