TXA in the Reduction of Post-Op Hematoma and Seroma in Patients Undergoing Panniculectomy or Abdominoplasty
Condition: Panniculectomy; Abdominoplasty
MeSH terms: Hematoma
Intervention: Tranexamic acid; Saline
Intervention description: After the abdominal skin and subcutaneous tissue is raised, the area will be irrigated, and hemostasis achieved using electrocautery. These steps are currently preformed with every panniculectomy. The Tranexamic acid soaked lap sponges will be unfolded and placed beneath the two lateral portions as well as the central area of the flap for 3 minutes. The lap sponges will not be "rung out" prior to placement. The surface area under the flap will be measured from the xiphoid process to the pubis, from the Xiphoid process to each anterior superior iliac spine (ASIS) and across from one ASIS to the other. These measurements will be used to calculate the surface area under the flap. These measurements will only be used in data collection and do not affect the principle aim of the study. The remainder of the surgical procedure will be the same for each patient.; After the abdominal skin and subcutaneous tissue is raised, the area will be irrigated, and hemostasis achieved using electrocautery. These steps are currently preformed with every panniculectomy. The saline soaked lap sponges will be unfolded and placed beneath the two lateral portions as well as the central area of the flap for 3 minutes. The lap sponges will not be "rung out" prior to placement. The surface area under the flap will be measured from the xiphoid process to the pubis, from the Xiphoid process to each anterior superior iliac spine (ASIS) and across from one ASIS to the other. These measurements will be used to calculate the surface area under the flap. These measurements will only be used in data collection and do not affect the principle aim of the study. The remainder of the surgical procedure will be the same for each patient.
Intervention MeSH terms: Tranexamic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be double-blinded. Participating patients will be randomized to receive normal saline (control group) or tranexamic acid (study population) on the day of surgery by the pharmacist. Normal saline is the current standard of care.
Each group will have 10 participants. Group 1 will undergo application of three normal saline soaked lap sponges to the surgical site. Group 2 will undergo application of three TXA soaked lap sponges to the surgical site. The lap sponges will be removed after three minutes and measurements will be taken for the study.
After discharge, post-operative drain output will be monitored and recorded by the patient on a provided drain documentation sheet. This does not differ from the current standard of care regarding drain output recordings.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Randomization of the patient is performed by the Pharmacist and entered into REDCap. Access to Patient Group and distributed drug (saline vs TXA) is restricted to the Pharmacist and the Study Coordinator.
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Panniculectomy; Abdominoplasty; Tranexamic acid

Summary:

      The purpose of this study is to study the use of a drug, tranexamic acid (TXA) to decrease
      bleeding and fluid collections in patients undergoing excision of excess lower abdominal skin
      and soft tissue, otherwise known as a panniculectomy. The use of TXA in this study is
      experimental. TXA is a medication currently used in many surgical subspecialties to control
      bleeding. TXA is approved by the FDA as a medication taken by mouth for the treatment of
      heavy menstrual bleeding and as an injection in patients with hemophilia for short-term use
      (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement
      therapy during and following tooth extraction.

      The use of TXA in this study is experimental, which means it is not approved by the FDA for
      topical use in decreasing bleeding during and after surgery. The results of this study will
      help the researchers determine if TXA is effective in decreasing blood loss following
      surgery. If effective, researchers hope this will result in earlier removal of post-operative
      drains leading to faster return to work or social activities
    

Eligibility criteria:

        Inclusion Criteria:

        • Patients undergoing panniculectomy or abdominoplasty.

        Exclusion Criteria:

          -  Prisoners

          -  Pregnant or nursing women

          -  Persons under the age of 18

          -  Preexisting coagulopathy

          -  Preexisting ongoing venous or arterial thrombosis

          -  History of cerebral vascular accident

          -  History of uncontrolled seizure disorder

          -  Documented administration of daily antiplatelet or anticoagulation (e.g.
             acetylsalicylic acid ,Non-steroidal anti-inflammatory drugs , Warfarin)

          -  Documented allergic reaction to tranexamic acid