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NCT Number: NCT06270407

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

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.

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Key information

Conditions

Surgical Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vejle Sykehus, Vejle, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid 100 MG/ML

Drug

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

Other names: Saline (placebo)

0.9%sodium chloride

Drug

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 outcomes

  1. Postoperative re-bleeding

    Time frame: 10 days

    • The primary objective is to demonstrate that topical application of TXA is superior to placebo (saline) in preventing postoperative bleeding needing intervention within the first 10 days after surgery. Thus, the null hypothesis to be tested in relation to the primary estimand is as follows:
    • Null hypothesis: Re-bleeding needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events within the first 10 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as case:
    • Re-operation
    • surgical exploration or evacuation
    • aspiration of hematoma
    • blood transfusion
    • external extra compression due to hematoma
    • Alternative hypothesis: Re-bleeding as defined above occurs less often with TXA than placebo (saline)

Secondary outcomes

  1. Postoperative wound infection

    Time frame: 30 days

    • Null hypothesis: Wound infection needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case:
    • Extra outpatient follow-up
    • Re-operation or surgical revision
    • Antibiotic treatment.
    • Alternative hypothesis: Wound infection as defined above occurs more often with TXA than placebo (saline)

  2. Postoperative wound rupture

    Time frame: 30 days

    • Null hypothesis: Wound rupture needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case:
    • Extra outpatient follow-up
    • Re-operation or surgical revision
    • Alternative hypothesis: Wound rupture as defined above occurs more often with TXA than placebo (saline)

  3. Postoperative seroma

    Time frame: 30 days

    • Null hypothesis: Seroma needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case:
    • Active aspiration of seroma
    • Passive spontaneous drainage of a significant volume of seroma
    • Alternative hypothesis: Seroma as defined above occurs more often with TXA than placebo (saline)

  4. Postoperative thromboembolic events

    Time frame: 30 days

    • Null hypothesis: Postoperative thromboembolic events, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case:
    • Deep venous thrombosis
    • Pulmonary embolus
    • Cerebral or coronary infarction
    • Alternative hypothesis: Thromboembolic events as defined above occurs more often with TXA than placebo (saline)

  5. Other possible adverse effects

    Time frame: 30 days

    Other possible adverse effects causing contact with the health service until 30 days postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Kjersti Ausen, MD PhD

CONTACT

[email protected]

+4792249693

Olav Spigset, MD PhD

CONTACT

[email protected]

+47 936 64 337

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Bærum sykehus
  • Hamar sykehus
  • Haraldsplass Deaconess Hospital
  • Helse Stavanger HF
  • Helsinki University Central Hospital
  • Oslo University Hospital
  • Smerud Medical Research International AS
  • Sykehuset SNR
  • Tynset Sykehus
  • University Hospital of North Norway
  • Vejle Hospital

Registry information

Official study title

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

Acronym: TRANOP

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 21, 2024
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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