Pharmacological-Aggravated Urticaria
Conditions
Brief summary
Different Methods of Tranexamic Acid Application in Controlling Peri-Operative Bleeding in Gynecomastia Surgery
Detailed description
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
Interventions
DRUGTranexamic acid injection
work aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Age (16 - 45 years) * Any grade of gynecomastia well be included
Exclusion criteria
* Age (\<16 - \>40 years) * History of previous gynecomastia surgery * Patients with known allergy to tranexamic acid * Patients with abnormal coagulation profile (according to American Society of Anesthesiologists guidelines for preoperative preparation of surgical patients) * Patients who are receiving treatment for known hyper-coagulable state. 6. Patients with history of cardiac disease or thromboembolic events.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss during liposuction in milliliters | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of surgical drain placement in days | 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. |
| Change in hemoglobin concentration from baseline to 24 hours post-operation | 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. |
| Extent of post-operative ecchymosis at 7 days | 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. |
| Changes in coagulation profile at 24 hours post-operation | 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. |
Contacts
Primary Contactamjad ahmed al-gubari, bchelor ged
Outcome results
None listed