Tranexamic Acid vs Thrombin for Skin Graft Complications

Overseen By Jessica Reynolds, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Kansas Medical Center

Must not be taking: Immunosuppressants

Disqualifiers: Uncontrolled diabetes, Peripheral vascular disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

62 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppression, you cannot participate in the trial.

What data supports the effectiveness of the drug Tranexamic Acid for reducing complications in skin grafts?

Research shows that Tranexamic Acid (TXA) is effective in reducing blood loss and the need for blood transfusions in various surgeries, including craniofacial and orthognathic surgeries. This suggests it may help reduce bleeding complications in skin graft procedures as well. ^{1 2 3 4 5}

Is Tranexamic Acid generally safe for use in humans?

Tranexamic Acid (TXA) is generally considered safe for use in various surgeries, with studies showing it effectively reduces blood loss and transfusion needs. However, it may increase the risk of seizures in cardiac surgery, and there are isolated reports of vascular issues like ulnar artery thrombosis. Overall, TXA has few adverse events, but more research is needed for certain surgical areas. ^{1 2 4 6 7}

How is the drug Tranexamic Acid different from other treatments for skin graft complications?

Tranexamic Acid (TXA) is unique because it helps prevent bleeding by stopping the breakdown of blood clots, which can be particularly useful in surgeries where bleeding is a concern. Unlike other treatments, TXA is an antifibrinolytic agent, meaning it specifically targets and reduces bleeding, making it a novel option for managing complications in skin grafts. ^{1 4 5 8 9}

What is the purpose of this trial?

Investigators hypothesize that topical tranexamic acid will have better or comparable efficacy to topical thrombin in reducing hematoma formation at the wound base. The purpose of the study is to demonstrate that topical tranexamic acid will be a non-inferior alternative medication to the current standard of care,THROMBIN-JMI® , and at a lower cost to the health system.

Research Team

Dhaval Bhavsar, MD

Principal Investigator

The University of Kansas Medical Center

Eligibility Criteria

This trial is for English or Spanish speakers with flame or scald burns covering 10% or less of their body. They must have a partial thickness burn and require a skin graft that's either meshed 1:1 or pie crusted if it's a small area, but not more than 5% deep partial/full thickness.

Inclusion Criteria

I have a burn injury from fire or hot liquid.

Less than 10% of my body has partial thickness burns.

My skin graft was taken at a specific depth and prepared in a certain way.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo surgery with either tranexamic acid or thrombin applied to the wound base during split thickness skin grafting

1 day

1 visit (in-person, surgical procedure)

Post-operative Care

Participants receive routine post-operative care in the burn unit with assessments at 48-72 hours, 7-10 days, and 14 days post-surgery

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hematoma occurrence and graft adherence

2 weeks

Treatment Details

Interventions

• Thrombin JMI
• Tranexamic Acid

Trial Overview The study is testing whether topical Tranexamic acid can be as effective as the standard Thrombin JMI in reducing hematoma formation under skin grafts after burns, potentially offering a cheaper option for treatment.

Participant Groups

Group I: Experimental Experimental Treatment 2 Interventions

Tranexamic acid solution will be sprayed onto the wound base after excision and prior to skin graft appliance in the same manner as the thrombin spray in the control group

Group II: Control Active Control 2 Interventions

Prior to application of the skin graft, a thin layer of thrombin is sprayed onto the wound base. The skin graft is then applied to the recipient site and fixated in standard fashion.

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Findings from Research

Tranexamic acid (TXA) can effectively reduce blood loss and the need for transfusions during pediatric craniosynostosis repair surgeries, which is important for improving surgical outcomes.

However, there are safety concerns associated with TXA, as demonstrated by a case of ulnar artery thrombosis in a patient who received TXA during cranial vault reconstructive surgery, highlighting the need for careful monitoring when using this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ulnar Artery Thrombosis Following Tranexamic Acid Administration for Craniosynostosis Repair. Chung, E., Karlberg, HI.[2019]

Tranexamic acid (TXA) significantly reduces blood loss and transfusion requirements in craniofacial and orthognathic surgeries, with reductions of 18.2 mL/kg and 156 mL respectively, based on a systematic review of 14 studies involving 7965 records.

While TXA shows promise in other plastic surgery areas like breast and reconstructive microsurgery, there is currently a lack of high-quality evidence (Level-1) for its efficacy in these fields, highlighting the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Tranexamic Acid in Cranio-Maxillofacial and Plastic Surgery. Murphy, GR., Glass, GE., Jain, A.[2022]

In a study of 44 patients undergoing deep-plane facelifts, intravenous tranexamic acid (TXA) was associated with decreased postoperative bruising and collections, indicating it may improve recovery outcomes.

While TXA did not significantly reduce intraoperative bleeding, it was found to be safe and could be a beneficial addition to surgical protocols, warranting further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Intravenous Tranexamic Acid During Rhytidectomy: A Randomized, Controlled, Double-Blind Pilot Study. Cohen, JC., Glasgold, RA., Alloju, LM., et al.[2021]

In a study of 115 patients undergoing interpolated flap repairs, those who received tranexamic acid (TXA) had significantly fewer bleeding events compared to those who did not, with only 1 event in the TXA group versus 27 in the non-TXA group.

The use of TXA resulted in a reduction in bleeding complications from 28.7% in the non-TXA group to just 4.8% in the TXA-treated group, highlighting its efficacy in preventing hemorrhagic complications after dermatologic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Prevention of Hemorrhagic Complications Following Interpolated Flap Repair: A Single-Center, Retrospective, Cohort Study. Freeman, SC., Heath, MS., Neill, B., et al.[2023]

In a study of 50 rhinoplasty patients, administering 10 mg/kg of Tranexamic acid (TXA) significantly reduced intraoperative bleeding compared to the control group, with an average of 213 mL versus 254 mL (P = 0.013).

TXA also significantly decreased postoperative eyelid edema and periorbital ecchymosis, leading to higher surgeon satisfaction, indicating its efficacy and safety in enhancing recovery after rhinoplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tranexamic acid on side effects of rhinoplasty: A randomized double-blind study. Ghavimi, MA., Taheri Talesh, K., Ghoreishizadeh, A., et al.[2018]

Tranexamic acid (TXA) significantly reduces perioperative blood loss in total shoulder arthroplasty (TSA), with a notable decrease in hemoglobin change, drain output, and total blood loss, particularly after reverse TSA, based on a meta-analysis of 6 studies involving 680 patients.

While TXA shows a trend towards reducing transfusion rates after reverse TSA, it did not significantly affect transfusion rates after anatomic TSA, indicating a need for further research to clarify its efficacy in different TSA types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tranexamic acid administration for anatomic and reverse total shoulder arthroplasty: a systematic review and meta-analysis. Box, HN., Tisano, BS., Khazzam, M.[2022]

Tranexamic acid (TXA) is effective in reducing blood loss and the need for blood transfusions across various types of surgeries, including orthopedic and cardiac procedures, based on a systematic review of 47 meta-analyses involving numerous outcomes.

TXA is generally safe, showing no increase in death or vascular adverse events, although it may pose a risk for seizures in cardiac surgery, highlighting the need for tailored dosing recommendations for different surgical types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Tranexamic Acid Reduce the Blood Loss in Various Surgeries? An Umbrella Review of State-of-the-Art Meta-Analysis. Hong, P., Liu, R., Rai, S., et al.[2022]

In a study involving 30 female patients, the Q-switched KTP laser treatment was found to be significantly more effective than intradermal injections of tranexamic acid (TXA) for reducing facial ephelides, with a greater decrease in pigmentation severity and melanin index.

While the laser treatment showed superior results, it also led to post-inflammatory hyperpigmentation in four patients, highlighting a potential safety concern compared to the TXA injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Q-Switched Nd:YAG (532 nm) Laser Versus Intra-Dermal Tranexamic Acid for Treatment of Facial Ephelides: A Split Face, Randomized, Comparative Trial. Sayed, KS., Tuqan, S., Hilal, RF.[2022]

Infiltrating tranexamic acid (TXA) into liposuction donor sites significantly reduced postoperative bruising, with a median bruising score of 1.6/10 compared to 2.3/10 in the control group, based on a study of 120 patients.

No adverse effects or differences in surgical complications were observed between the TXA group and the control group, indicating that TXA is a safe option for minimizing ecchymosis in plastic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Infiltration of Tranexamic Acid (TXA) in Liposuction: A Single-Surgeon Outcomes Analysis and Considerations for Minimizing Postoperative Donor Site Ecchymosis. Weissler, JM., Banuelos, J., Molinar, VE., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ulnar Artery Thrombosis Following Tranexamic Acid Administration for Craniosynostosis Repair. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Tranexamic Acid in Cranio-Maxillofacial and Plastic Surgery. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effects of Intravenous Tranexamic Acid During Rhytidectomy: A Randomized, Controlled, Double-Blind Pilot Study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Tranexamic Acid Prevention of Hemorrhagic Complications Following Interpolated Flap Repair: A Single-Center, Retrospective, Cohort Study. [2023]

5. Scotland pubmed.ncbi.nlm.nih.gov

Efficacy of tranexamic acid on side effects of rhinoplasty: A randomized double-blind study. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Tranexamic acid administration for anatomic and reverse total shoulder arthroplasty: a systematic review and meta-analysis. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Does Tranexamic Acid Reduce the Blood Loss in Various Surgeries? An Umbrella Review of State-of-the-Art Meta-Analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Q-Switched Nd:YAG (532 nm) Laser Versus Intra-Dermal Tranexamic Acid for Treatment of Facial Ephelides: A Split Face, Randomized, Comparative Trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Local Infiltration of Tranexamic Acid (TXA) in Liposuction: A Single-Surgeon Outcomes Analysis and Considerations for Minimizing Postoperative Donor Site Ecchymosis. [2021]