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
St. Olavs Hospital
Smerud Medical Research International AS
Oslo University Hospital
Haraldsplass Deaconess Hospital
Helse Stavanger HF
University Hospital of North Norway
Helsinki University Central Hospital
Vejle Hospital
Bærum sykehus
Sykehuset SNR
Hamar sykehus
Tynset Sykehus
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative re-bleeding | 10 days | * The primary objective is to demonstrate that topical application of TXA is superior to placebo (saline) in preventing postoperative bleeding needing intervention within the first 10 days after surgery. Thus, the null hypothesis to be tested in relation to the primary estimand is as follows: * Null hypothesis: Re-bleeding needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events within the first 10 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as case: * Re-operation * surgical exploration or evacuation * aspiration of hematoma * blood transfusion * external extra compression due to hematoma * Alternative hypothesis: Re-bleeding as defined above occurs less often with TXA than placebo (saline) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative wound infection | 30 days | * Null hypothesis: Wound infection needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case: * Extra outpatient follow-up * Re-operation or surgical revision * Antibiotic treatment. * Alternative hypothesis: Wound infection as defined above occurs more often with TXA than placebo (saline) |
| Postoperative wound rupture | 30 days | * Null hypothesis: Wound rupture needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case: * Extra outpatient follow-up * Re-operation or surgical revision * Alternative hypothesis: Wound rupture as defined above occurs more often with TXA than placebo (saline) |
| Postoperative seroma | 30 days | * Null hypothesis: Seroma needing intervention, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case: * Active aspiration of seroma * Passive spontaneous drainage of a significant volume of seroma * Alternative hypothesis: Seroma as defined above occurs more often with TXA than placebo (saline) |
| Postoperative thromboembolic events | 30 days | * Null hypothesis: Postoperative thromboembolic events, defined as the dicotome variable occurrence or absence of one of more of the below defined events with within the first 30 postoperative days, occurs with the same incidence in wounds treated with topical TXA versus topical placebo (saline). One or several of the following will qualify as a case: * Deep venous thrombosis * Pulmonary embolus * Cerebral or coronary infarction * Alternative hypothesis: Thromboembolic events as defined above occurs more often with TXA than placebo (saline) |
| Other possible adverse effects | 30 days | Other possible adverse effects causing contact with the health service until 30 days postoperatively |
Countries
Denmark, Finland, Norway
Contacts
CONTACTKjersti Ausen, MD PhD
CONTACTOlav Spigset, MD PhD
PRINCIPAL_INVESTIGATORKjersti Ausen, MD PhD
St Olav's University Hospital
Outcome results
None listed