A Phase 4 interventional study of Tranexamic acid and Saline in Panniculectomy and Abdominoplasty, sponsored by The Reading Hospital and Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by The Reading Hospital and Medical Center · Phase 4, Interventional, and Supportive care
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
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.
The Reading Hospital and Medical Center is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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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
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
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
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.
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.
Time frame: 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.
Time frame: Up to 8 weeks postoperatively
Number of Participants That Returned to the Operating Room
Return to the operating room for evacuation post surgical operative hematoma or seroma assessed by clinical evaluation to include palpation for ballotable fluid collection and assessment of skin for a shiny/tight appearance suggestive of an underlying fluid collection.
Time frame: Up to 8 weeks postoperatively
Number of Days Until Drain Removal
The number of days that the post surgical drains remain in place after the surgery. When less than 30 cc per drain in a 24-hour period, the participants are to call and schedule drain removal.
Time frame: Up to 56 days post operatively.
| Milestone | Group 1 | Group 2 |
|---|---|---|
| Started | 4 | 5 |
| Completed | 4 | 5 |
| Not completed | 0 | 0 |
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.
No measurements were reported for this outcome.
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.
| Participants | Group 1 | Group 2 |
|---|---|---|
| Participants With Post Operative Hematoma | 0 | 1 |
Return to the operating room for evacuation post surgical operative hematoma or seroma assessed by clinical evaluation to include palpation for ballotable fluid collection and assessment of skin for a shiny/tight appearance suggestive of an underlying fluid collection.
| Participants | Group 1 | Group 2 |
|---|---|---|
| Number of Participants That Returned to the Operating Room | 0 | 0 |
The number of days that the post surgical drains remain in place after the surgery. When less than 30 cc per drain in a 24-hour period, the participants are to call and schedule drain removal.
| Days | Group 1 | Group 2 |
|---|---|---|
| Number of Days Until Drain Removal | 16 (11 to 24) | 22 (15 to 39) |
Collected over 8 weeks postoperatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Group 2 | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| Event | Group 1 | Group 2 |
|---|---|---|
| Drain sizeSurgical and medical procedures | 4/4 | 1/5 |
| Error in number of spongesSurgical and medical procedures | 4/4 | 2/5 |
| Drain outputSurgical and medical procedures | 3/4 | 1/5 |
| Age, Continuous(years) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 39 (36 to 46) | 46 (37 to 58) | 43 (36 to 58) |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 4 | 6 |
| Not Hispanic or Latino | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 2 | 2 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Total |
|---|---|---|---|
| United States | 4 | 5 | 9 |
| Height(meters) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 1.58 (1.55 to 1.63) | 1.65 (1.58 to 1.70) | 1.62 (1.55 to 1.70) |
| Weight(kgs) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 71.5 (62.8 to 76.4) | 76.1 (72.6 to 84.3) | 74.1 (62.8 to 84.3) |
| BMI(kg/m^2) | Group 1 | Group 2 | Total |
|---|---|---|---|
| Mean | 28.6 (23.75 to 30.8) | 27.5 (25.06 to 29.83) | 28 (23.75 to 30.8) |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Tranexamic Acid
The Reading Hospital and Medical Center