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

Phase 4

Recruiting

• Conditions: Surgical Complication
• Interventions: Drug: Tranexamic Acid 100 MG/ML; Drug: 0.9%sodium chloride

• Registration Number: NCT06270407
• Lead Sponsor: St. Olavs Hospital

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.

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-21
• Study Start: 2024-10-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid arm	Tranexamic Acid 100 MG/ML	Anonymous ampoule containing 5 ml of 100 mg/ml Tranexamic Acid. 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.
Placebo arm	0.9%sodium chloride	Anonymous ampoule containing 5 ml of 0.9% NaCl. 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

Name	Time	Method
Postoperative re-bleeding	10 days	• Comparison between wounds receiving TXA versus placebo of the incidence of postoperative re-bleeding within the first postoperative 10 days

Secondary Outcome Measures

Name	Time	Method
Postoperative thromboembolic events	30 days	• Comparison between wounds receiving TXA versus placebo of the incidence of • thromboembolic events defined as thrombophlebitis, deep venous thrombosis, pulmonary embolus, cerebral or coronary infarctions until 30 days postoperatively
Postoperative wound infection	30 days	• Comparison between wounds receiving TXA versus placebo of the incidence of postoperative wound infection within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision or antibiotic treatment.
Postoperative wound rupture	30 days	• Comparison between wounds receiving TXA versus placebo of the incidence of wound rupture within the first 30 days requiring any of the following: Extra outpatient follow-up, re-operation, or revision.
Postoperative seroma	Between day 10 and 30	• Comparison between wounds receiving TXA versus placebo of the incidence of • seroma defined as the need for aspiration of fluids, or spontaneous evacuation of voluminous fluids, between 10 and 30 days postoperatively
Any other postoperative complication	30 days	• Comparison between wounds receiving TXA versus placebo of the incidence of • other possible adverse effects causing contact with the health service until 30 days postoperatively.

Trial Locations

Locations (1)

St Olav's University Hospital; 🇳🇴 Trondheim, Norway