Clinical trial NCT06270407: The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery
Official title: The Effect of Topical Tranexamic Acid on Postoperative Complications in Soft Tissue Plastic Surgery - A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Surgical Complication
Keywords: tranexamic acid postoperative bleeding infection wound rupture seroma thromboembolism
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Smerud Medical Research International AS
name: Sykehuset Asker og Baerum
name: Oslo University Hospital
name: Sykehuset Telemark
name: Sykehuset Innlandet HF
name: Molde Hospital
name: Haukeland University Hospital
name: Haraldsplass Deaconess Hospital
name: Helse Stavanger HF
name: University Hospital of North Norway
name: Bodø sykehus
name: Helsinki University Central Hospital
First posted: 2024-02-21
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled prospective interventional trial
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: Postoperative re-bleeding
timeFrame: 10 days
Secondary outcomes:
measure: Postoperative wound infection
timeFrame: 30 days
measure: Postoperative wound rupture
timeFrame: 30 days
measure: Postoperative thromboembolic events
timeFrame: 30 days
measure: Postoperative seroma
timeFrame: Between day 10 and 30
measure: Any other postoperative complication
timeFrame: 30 days
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olav's University Hospital
Study officials:
affiliation: St Olav's University Hospital
name: Kjersti Ausen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: