TXA in the Reduction of Post-Op Hematoma and Seroma in Patients Undergoing Panniculectomy or Abdominoplasty

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

Conditions

• Panniculectomy
• Abdominoplasty

Interventions

DRUG

Tranexamic acid

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.

DRUG

Saline

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.

Sponsors & Collaborators

• The Reading Hospital and Medical Center

  lead OTHER

Principal Investigators

• Amir Behnam, MD · Reading Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-17

Primary Completion

2021-05-06

Completion

2021-05-06

FDA Drug

Yes

Countries

• United States

Study Locations