Comparison of bleeding control using tranexamic acid irrigation and sterile gauze impregnated with tranexamic acid irrigation in bimaxillary orthognathic surgery

Comparison of bleeding control using tranexamic acid irrigation and sterile gauze impregnated with tranexamic acid irrigation in bimaxillary orthognathic surgery: a randomized controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250309064996N1

Enrollment

Registered

2025-03-11

Start date

2025-04-09

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Dentofacial anomalies. Other congenital malformations of face and neck, Cleft palate with cleft lip

Interventions

Intervention 1: Intervention group: Gauze or G, In the intervention group, normal saline solution is used to wash and cool the rotary instruments, but to control bleeding, we use sterile gauze soaked

Eligibility

Sex/Gender

All

Age

15 Years to 45 Years

Inclusion criteria

Inclusion criteria: patients between 15 and 45 years old requiring elective bimaxillary orthognathic surgery patient who are according to American society of anesthesiologists classified as ASA 1.

Exclusion criteria

Exclusion criteria: patients with coagulopathy(according to examinations and medical history) patient currently taking anticoagulants patients with hepatic faliure immunodeficient patients patients requiring genioplasty, bone augmentation , lefort 2 or lefort 3 procedures patients requiring segmental lefort procedure patients facing complications during surgery ( such as descending palatin artery rupture, unfavorable fracture and etc.)

Design outcomes

Primary

Measure	Time frame
Blood loss. Timepoint: Amount of blood lost during surgery. Method of measurement: Measuring the volume of blood in the suction reservoir and sterile gauzes used during surgery.	—

Secondary

Measure	Time frame
Hemoglobin drop. Timepoint: The rate of decrease in hemoglobin after surgery. Method of measurement: CBC (Post op. & Pre op.).;Hematocrit drop. Timepoint: The rate of decrease in hematocrit after surgery. Method of measurement: CBC (Post op. & Pre op.).;Platelet count drop. Timepoint: The rate of decrease in platelet count after surgery. Method of measurement: CBC (Post op. & Pre op.).;Procedure duration. Timepoint: Duration of the operation from the start of anesthesia to the start of recovery. Method of measurement: Time based on minutes.;Blood transfusion. Timepoint: Need for blood transfusion during surgery. Method of measurement: Recorded in the patient's file.	—

Measure

Time frame

Hemoglobin drop. Timepoint: The rate of decrease in hemoglobin after surgery. Method of measurement: CBC (Post op. & Pre op.).;Hematocrit drop. Timepoint: The rate of decrease in hematocrit after surgery. Method of measurement: CBC (Post op. & Pre op.).;Platelet count drop. Timepoint: The rate of decrease in platelet count after surgery. Method of measurement: CBC (Post op. & Pre op.).;Procedure duration. Timepoint: Duration of the operation from the start of anesthesia to the start of recovery. Method of measurement: Time based on minutes.;Blood transfusion. Timepoint: Need for blood transfusion during surgery. Method of measurement: Recorded in the patient's file.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Golkar

Shahid Beheshti University of Medical Sciences

Mohsen_golkarparvin@yahoo.com+98 21 2240 3075

Outcome results

None listed

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