Clinical trial NCT04902950: TXA in the Reduction of Post-Op Hematoma and Seroma in Patients Undergoing Panniculectomy or Abdominoplasty
Official title: Role of Tranexamic Acid (TXA) in the Reduction of Post-operative Hematoma and Seroma in Patients Undergoing Panniculectomy or Abdominoplasty, a Pilot Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Panniculectomy
Abdominoplasty
Keywords: Panniculectomy
Abdominoplasty
Tranexamic acid
Lead sponsor: The Reading Hospital and Medical Center
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed description: Participants consented to take part in this study will be assigned by chance to receive either placebo (Group 1) or TXA (Group 2) during the surgical procedure. This study will be double-blinded, in that neither the patient nor the surgeon will know to which treatment, (placebo vs. TXA) that the patient will receive. 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. Double blinding ensures that the researcher or the patient's opinion does not influence study results, however this information is available from the pharmacy in the event of any complications.

Each group will have 10 participants. The solution of either saline or TXA will be placed into a sterile bowl in the operating area and three lap sponges will be placed in the solution at the beginning of the procedure. 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. All patients who receive a post-surgical drain are asked to document output. All patients will be educated on routine drain care and recording drain output.

Patients will not need to undergo any extra medical tests, medical procedures or doctor visits if they decide to join the study. Patient participation in the study begins upon signature of the consent form and is expected to last no more than 8 weeks following the patient's surgical procedure.

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

Primary outcomes:
measure: Post Surgical Drain Output in CCs
timeFrame: Up to eight weeks post-operatively
measure: Participants With Post Operative Hematoma
timeFrame: Up to 8 weeks postoperatively
Secondary outcomes:
measure: Number of Participants That Returned to the Operating Room
timeFrame: Up to 8 weeks postoperatively
measure: Number of Days Until Drain Removal
timeFrame: Up to 56 days post operatively.
Other outcomes:
Locations:
city: West Reading
country: United States
facility: Reading Hospital
state: Pennsylvania
Study officials:
affiliation: Reading Hospital
name: Amir Behnam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD010562. doi: 10.1002/14651858.CD010562.pub2.
citation: Maj Richard Reed, RAMC, LtCol Tom Woolley, RAMC Continuing Education in Anaesthesia Critical Care & Pain, Volume 15, Issue 1, February 2015, Pages 32-37, https://doi.org/10.1093/bjaceaccp/mku009 Published: 30 May 2014
citation: Masoomi H, Rimler J, Wirth GA, Lee C, Paydar KZ, Evans GRD. Frequency and risk factors of blood transfusion in abdominoplasty in post-bariatric surgery patients: data from the nationwide inpatient sample. Plast Reconstr Surg. 2015 May;135(5):861e-868e. doi: 10.1097/PRS.0000000000001161.
citation: Jimenez JJ, Iribarren JL, Lorente L, Rodriguez JM, Hernandez D, Nassar I, Perez R, Brouard M, Milena A, Martinez R, Mora ML. Tranexamic acid attenuates inflammatory response in cardiopulmonary bypass surgery through blockade of fibrinolysis: a case control study followed by a randomized double-blind controlled trial. Crit Care. 2007;11(6):R117. doi: 10.1186/cc6173.
citation: Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878.
citation: Rohrich RJ, Cho MJ. The Role of Tranexamic Acid in Plastic Surgery: Review and Technical Considerations. Plast Reconstr Surg. 2018 Feb;141(2):507-515. doi: 10.1097/PRS.0000000000003926.