Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06509256

Different Methods of Tranexamic Acid Application in Controlling Peri Operative Bleeding in Gynecomastia Surgery

Different Methods of Tranexamic Acid Application in Controlling Peri-Operative Bleeding in Gynecomastia Surgery

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

16 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic acid injection

Drug

work aims to evaluate the role of tranexamic acid in bleeding control in gynecomastia surgery

Primary outcomes

  1. Intraoperative blood loss during liposuction in milliliters

    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.

Secondary outcomes

  1. Duration of surgical drain placement in days

    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.

  2. Change in hemoglobin concentration from baseline to 24 hours post-operation

    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.

  3. Extent of post-operative ecchymosis at 7 days

    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."

  4. Changes in coagulation profile at 24 hours post-operation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

amjad ahmed al-gubari, bchelor ged

CONTACT

[email protected]

01080769394 ext. 0882315377

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Different Methods of Tranexamic Acid Application in Controlling Perio Operative Bleeding in Gynecomastia

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.