Surgical Complication
Conditions
Keywords
tranexamic acid postoperative bleeding infection wound rupture seroma thromboembolism
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.
Interventions
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
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.
Sponsors
Smerud Medical Research International AS
Sykehuset Asker og Baerum
Oslo University Hospital
Sykehuset Telemark
Sykehuset Innlandet HF
Molde Hospital
Haukeland University Hospital
Haraldsplass Deaconess Hospital
Helse Stavanger HF
University Hospital of North Norway
Bodø sykehus
Helsinki University Central Hospital
St. Olavs Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized controlled prospective interventional trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Countries
Norway
Contacts
Primary ContactKjersti Ausen, MD PhD
Backup ContactOlav Spigset, MD PhD
Outcome results
None listed