Tranexamic acid injection
Drugwork aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery
NCT Number: NCT06509256
Different Methods of Tranexamic Acid Application in Controlling Peri-Operative Bleeding in Gynecomastia Surgery
Trial opening soon.
Get Notified16 year–45 year
Male
Interventional
Early Phase 1
The term "gynecomastia" is derived from the Greek words "gyne" = woman and "mastos" = breast and is a benign enlargement of the male breast. It is the most common condition affecting the male breast due to enlargement of both ductal and stromal tissue[1].
Plastic surgeons frequently perform gynecomastia operations as cosmetic procedures. Since these operations result in relatively little blood loss, there is little information in the literature about how to minimise blood loss during these cosmetic procedures Some preventive measure against bleeding and hematomas include perioperative blood pressure control, use compressive dressing, different types of suction drains, size of incision, careful hemostasis, and infusion of adrenalin during local anesthesia, infusion of tranexamic acid in tumescent or intravenous directly
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
work aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery
Time frame: "Intraoperatively" Unit of Measure: Milliliters (mL)
The volume of blood collected in the liposuction bottle during the surgical procedure will be measured. This will be reported as mean volume in milliliters with standard deviation for each study group.
Time frame: From immediate post-operation until drain removal (expected within 3 to 7 days)" Unit of Measure: Days
The number of days the surgical drain remains in place post-operatively, until drainage is less than 30 mL per 24 hours. This will be reported as mean number of days with standard deviation for each study group.
Time frame: Baseline (within 24 hours before surgery) and 24 hours post-operation" Unit of Measure: Grams per deciliter (g/dL)
The difference in hemoglobin concentration between preoperative baseline and 24 hours post-operation. This will be reported as mean change in g/dL with standard deviation for each study group.
Time frame: "7 days post-operation" Unit of Measure: Ordinal scale score (0-4)
The extent of ecchymosis will be assessed using a standardized photographic scale, ranging from 0 (no ecchymosis) to 4 (severe ecchymosis). This will be reported as median score with interquartile range for each study group."
Time frame: "Baseline (within 24 hours before surgery) and 24 hours post-operation" Unit of Measure: Seconds for PT and aPTT, no units for INR
Changes in prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR) from baseline to 24 hours post-operation. These will be reported as mean changes with standard deviations for each parameter in each study group.
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Different Methods of Tranexamic Acid Application in Controlling Perio Operative Bleeding in Gynecomastia
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