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

NCT04902950 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IRB 003-20
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Panniculectomy; Abdominoplasty

Keywords

Panniculectomy; Abdominoplasty; Tranexamic acid

Outcome Measures

Primary Outcomes (2)

• Post Surgical Drain Output in CCs

  Patient recorded, post operative drain output. Patients will track their 24-hour total drain output by recording the 24-hour total output at 10 am every day. If the output exceeds the drain capacity during the 24-hour interval but before the 10am empty time, the patient will empty the drain when full, record that output, allow the drain output to reaccumulate, and empty-record the drain output again at 10am or again when the output exceeds the drain capacity. The individual outputs recorded during the 24-hour interval will then be totaled to determine one output sum for the entire 24-hour time period between 10am time intervals. Each drain bulb will accommodate a maximum of 60cc of postoperative fluid. Drain removal will occur when output is less than 30 cc per drain in 24-hour period or eight weeks post-operatively.

  Up to eight weeks post-operatively

• Participants With Post Operative Hematoma

  Patients will be monitored clinically at each post-operative visit for signs of post-operative hematoma or seroma. Each patient will be evaluated one week, three weeks, and eight weeks following their procedure to assess overall wound healing.

  Up to 8 weeks postoperatively

Secondary Outcomes (2)

• Number of Participants That Returned to the Operating Room

  Up to 8 weeks postoperatively

• Number of Days Until Drain Removal

  Up to 56 days post operatively.

Study Arms (2)

Group 1

PLACEBO COMPARATOR

The solution of saline 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. The lap sponges will be removed after three minutes and measurements will be taken for the study.

Drug: Saline

Group 2

EXPERIMENTAL

The solution of Tranexamic Acid (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 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.

Drug: Tranexamic acid

Interventions

Tranexamic acid DRUG

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.

Also known as: TXA

Group 2

Saline DRUG

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing panniculectomy or abdominoplasty.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Reading Hospital and Medical Center: lead

Study Sites (1)

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Related Publications (6)

• 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.

  PMID: 23881695 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25919268 BACKGROUND

• 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.

  PMID: 17988379 BACKGROUND

• 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.

  PMID: 26349843 BACKGROUND

• 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.

  PMID: 28938364 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Amir Behnam, MD
• Organization: Reading Hospital

amir.behnam@towerhealth.org

610-988-9127

Study Officials

• Amir Behnam, MD

  Reading Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD FACS Chief, Division of Plastic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 26, 2021
• Study Start: August 17, 2020
• Primary Completion: May 6, 2021
• Study Completion: May 6, 2021
• Last Updated: April 25, 2023
• Results First Posted: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)