Using tranexamic acid on surgical wounds to reduce complications

The Effect of Topical Tranexamic Acid on Postoperative Complications in Soft Tissue Plastic Surgery - A Multicenter Randomized Controlled Trial

This study is testing if applying tranexamic acid to surgical wounds can help reduce complications like bleeding and infections for people undergoing plastic surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: St. Olavs Hospital (Academic / other)
• Locations: 1 site (Trondheim)
• Trial ID: NCT06270407 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of applying tranexamic acid (TXA) directly onto surgical wounds in plastic surgery to determine if it can reduce postoperative complications such as re-bleeding, infections, and wound ruptures. Participants will receive either TXA or a placebo at the end of their surgery, with neither the patients nor the study personnel aware of which treatment is administered. The study will monitor complications for 30 days post-surgery through medical record reviews, electronic self-reporting, and follow-up calls. A total of 1500 patients will be enrolled in each group to assess the efficacy of TXA compared to placebo.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 undergoing plastic surgical procedures that typically involve the use of topical TXA.

Not a fit: Patients with known allergies to tranexamic acid or those who cannot provide informed consent will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of postoperative complications in plastic surgery patients.

How similar studies have performed: Previous studies have shown promising results with the use of tranexamic acid in reducing surgical complications, suggesting this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Patients are eligible to be included in the study only if all of the following criteria apply:

  1. They are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center.
  2. They are over 18 years of age and capable of independently providing informed consent
  3. They have received adequate oral and written information about the study and signed the informed-consent form

Exclusion Criteria:

* Patients with known allergy to tranexamic acid. Insufficient knowledge of national language or English.

Where this trial is running

Trondheim

• St Olav's University Hospital — Trondheim, Norway (Recruiting)

Study contacts

• Principal investigator: Kjersti Ausen, MD PhD — St Olav's University Hospital
• Study coordinator: Kjersti Ausen, MD PhD

Conditions Surgical Complication; tranexamic acid postoperative bleeding infection wound rupture seroma thromboembolism