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TXA in the Reduction of Post-Op Hematoma and Seroma in Patients Undergoing Panniculectomy or Abdominoplasty
Phase 4 trial testing Tranexamic acid in Panniculectomy in 9 participants. Terminated before completion.
| Lead sponsor | The Reading Hospital and Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 9 |
| Start date | 17 August 2020 |
| Primary completion | 6 May 2021 |
| Estimated completion | 6 May 2021 |
| Sites | 1 location across United States |
The Reading Hospital and Medical Center
18 and older, any sex, with Panniculectomy or Abdominoplasty. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Group 1 | 0 | |
| Group 2 | 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.
| Group | Value | 95% CI |
|---|---|---|
| Group 1 | 0 | |
| Group 2 | 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.
| Group | Value | 95% CI |
|---|---|---|
| Group 1 | 16 | 11 – 24 |
| Group 2 | 22 | 15 – 39 |
Time frame: 8 weeks postoperatively. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Group 1 | Group 2 |
|---|---|---|---|
| Drain size | Surgical and medical procedures | — | — |
| Error in number of sponges | Surgical and medical procedures | — | — |
| Drain output | Surgical and medical procedures | — | — |
Data from ClinicalTrials.gov NCT04902950 adverse events section.
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
No peer-reviewed publications indexed yet for this trial.
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