Abdominoplasty, Panniculectomy
Conditions
Keywords
Panniculectomy, Abdominoplasty, Tranexamic acid
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.
Interventions
DRUGTranexamic 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.
DRUGSaline
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
The Reading Hospital and Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, 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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Post Operative Hematoma | Up to 8 weeks postoperatively | 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. |
| Post Surgical Drain Output in CCs | Up to eight weeks post-operatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Returned to the Operating Room | Up to 8 weeks postoperatively | 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. |
| Number of Days Until Drain Removal | Up to 56 days post operatively. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 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.
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. | 4 |
| Group 2 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.
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. | 5 |
| Total | 9 |
Baseline characteristics
| Characteristic | Group 1 | Total | Group 2 |
|---|---|---|---|
| Age, Continuous | 39 years | 43 years | 46 years |
| BMI | 28.6 kg/m^2 | 28 kg/m^2 | 27.5 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 1.58 meters | 1.62 meters | 1.65 meters |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 4 participants | 9 participants | 5 participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 71.5 kgs | 74.1 kgs | 76.1 kgs |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 |
| other Total, other adverse events | 4 / 4 | 3 / 5 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 |
Outcome results
Primary
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
Population: This is a count of the number of patients that experienced post operative hematoma.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Participants With Post Operative Hematoma | 0 Participants |
| Group 2 | Participants With Post Operative Hematoma | 1 Participants |
Primary
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
Population: Data did not undergo analysis due to errors in data collection. Subjects were to have two 15 round Blake drains, however some of the subjects received French drains. Drain output was to be self recorded by the patient and was found to be inconsistent per data collection. The data was not analyzed due to small sample size and errors in the data collection process. As this study was a pilot, it was terminated for logistical concerns with these errors.
Secondary
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.
Population: The average number of days that the participants endured the drains after surgery.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | Number of Days Until Drain Removal | 16 Days |
| Group 2 | Number of Days Until Drain Removal | 22 Days |
Secondary
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
Population: This measure describes the number of patients in counts, that returned to the operating room for fluid collection.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1 | Number of Participants That Returned to the Operating Room | 0 Participants |
| Group 2 | Number of Participants That Returned to the Operating Room | 0 Participants |