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

Surgical Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06270407
• Other study ID #: 270777
• Secondary ID: 2022-001580-2820
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2024
• Source: St. Olavs Hospital
• Contact: Kjersti Ausen, MD PhD
• Phone: +4792249693
• Email: kjerstiausen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications
• Surgical Complication

Intervention

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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (13)

Lead Sponsor	Collaborator
St. Olavs Hospital	Bodø sykehus, Haraldsplass Deaconess Hospital, Haukeland University Hospital, Helse Stavanger HF, Helsinki University Central Hospital, Molde Hospital, Oslo universitetssykehus HF, Smerud Medical Research International AS, Sykehuset Asker og Baerum, Sykehuset Innlandet HF, Sykehuset Telemark, University Hospital of North Norway

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative re-bleeding	• Comparison between wounds receiving TXA versus placebo of the incidence of postoperative re-bleeding within the first postoperative 10 days	10 days
Secondary	Postoperative wound infection	• 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.	30 days
Secondary	Postoperative wound rupture	• 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.	30 days
Secondary	Postoperative thromboembolic events	• 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	30 days
Secondary	Postoperative seroma	• 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	Between day 10 and 30
Secondary	Any other postoperative complication	• 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.	30 days