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

NCT06270407 | Recruiting Phase 4 DMC

• 3 other identifiers: 2707772022-001580-282023-510381-28-01
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Complication

Keywords

tranexamic acid postoperative bleeding infection wound rupture seroma thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative wound infection

  30 days

• Postoperative wound rupture

  30 days

• Postoperative thromboembolic events

  30 days

• Postoperative seroma

  Between day 10 and 30

• Any other postoperative complication

  30 days

Study Arms (2)

Tranexamic acid arm

ACTIVE COMPARATOR

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.

Drug: Tranexamic Acid 100 MG/ML

Placebo arm

PLACEBO COMPARATOR

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.

Drug: 0.9%sodium chloride

Interventions

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

Also known as: Saline (placebo)

Tranexamic acid arm

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.

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with known allergy to tranexamic acid. Insufficient knowledge of national language or English.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Smerud Medical Research International AS: collaborator
• Sykehuset Asker og Baerum: collaborator
• Oslo University Hospital: collaborator
• Sykehuset Telemark: collaborator
• Sykehuset Innlandet HF: collaborator
• Molde Hospital: collaborator
• Haukeland University Hospital: collaborator
• Haraldsplass Deaconess Hospital: collaborator
• Helse Stavanger HF: collaborator
• University Hospital of North Norway: collaborator
• Bodø sykehus: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (1)

St Olav's University Hospital

Trondheim, 7006, Norway

RECRUITING

MeSH Terms

Interventions

Tranexamic Acid; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kjersti Ausen, MD PhD

  St Olav's University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kjersti Ausen, MD PhD

CONTACT

+4792249693; kjerstiausen@gmail.com

Olav Spigset, MD PhD

CONTACT

+47 936 64 337; olav.spigset@legemidler.no

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identically shaped ampoules containing traneamic acid (Cyklokapron, Pfizer) and 0.9% Saline (Lavoisier, France) have been identified. The ampoule top part is camouflaged with a tight-fitting black tube which preserves the breaking point on the neck of the ampoule. The ampoules will be re-labeled with study-specific labels (text will be in accordance with Regulation 546/2014, annex VI). Randomized study envelopes will be provided in packages of two, with a 1:1 TXA:Placebo randomization, enabling a within-patient randomization in bilateral procedures. Randomization, blinding, labelling, shipment of ampoules and keeping of the randomization code will be done by Smerud Medical Research International AS.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled prospective interventional trial

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after the completion and publication of the study and will remain available upon reasonable request. Data will be stored for 25 years.
• Access Criteria: First or last author must be contacted with a detailed description of what data is needed for. Whether data will be shared must be determined by the investigators and possibly by the regional ethic committee.

Locations

NO (1)