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Recruiting NCT06270407

The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery

Phase IV Interventional Surgical Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tranexamic Acid 100 MG/ML, 0.9%sodium chloride.
Who it may be relevant to
Registry conditions: Surgical Complication. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

Study objective: This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots. Eligible patients: Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery. Study intervention: Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules.

Detailed description

Any serious postoperative complication needing intervention, specifically re-bleeding, wound infection, wound rupture, or the occurrence of blood clots for the first 30 days after surgery will be registered through the following interventions:

* Screening of patient medical records * Distribution of an electronic self-report form (eForsk®) to participating patients at postoperative day 30 * Follow-up phone call to verify data after day 30.

The study is terminated after the final phone call. All study data will be registered in an electronic, pseudonymous web-based registration form (eCRF/Viedoc®).

Number of participants: To assess the effect of TXA on the defined surgical complications compared to placebo, 1500 patients are needed in each group.

Data monitoring committee:

A data monitoring committee consisting of a group of independent scientists will be appointed for this study to monitor the safety and scientific integrity of this human research intervention.

Interventions

  • Drug Tranexamic Acid 100 MG/ML
    If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using tranexamic acid
  • Drug 0.9%sodium chloride
    If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.

Primary outcome measures

  • Postoperative re-bleeding [Time frame: 10 days]
Secondary outcome measures (5)
  • Postoperative wound infection [Time frame: 30 days]
  • Postoperative wound rupture [Time frame: 30 days]
  • Postoperative thromboembolic events [Time frame: 30 days]
  • Postoperative seroma [Time frame: Between day 10 and 30]
  • Any other postoperative complication [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Patients are eligible to be included in the study only if all of the following criteria apply:
  • 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.
  • They are over 18 years of age and capable of independently providing informed consent
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Norway · 1 center
  • St Olav's University Hospital — Trondheim

Identifiers

NCT: NCT06270407 · 270777 · 2022-001580-28 · 2023-510381-28-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗