Breast Neoplasms, Postoperative Hemorrhage, Seroma
Conditions
Keywords
Administration, topical, Tranexamic acid, Postoperative care, Mastectomy
Brief summary
After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer. After surgery for breast cancer patients may also experience problems with long lasting seroma. Therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.
Interventions
DRUGTranexamic Acid
moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
DRUGsaline
moisten the surgical wound surface with 20 ml placebo (0.9% saline)
Sponsors
Alesund Hospital
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* breast cancer * undergoing unilateral mastectomy with or without axillary node dissection * received adequate oral and written information about the study and signed an informed-consent form
Exclusion criteria
* pregnant or breastfeeding * known thromboembolic disease or with high risk of thromboembolism, warranting extra anticoagulation in connection with the procedure * known allergy to tranexamic acid/Cyklokapron®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bleeding as defined by drain production per hour the first 24 hours | 24 hours postoperatively | Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily drain production up to drain removal - cumulative volume | 3 weeks | — |
| number of patients having surgical bleeding in need of re-operation | 3 weeks | — |
| number of postoperative aspirations of clinical seroma | up to 3 months | — |
| chronic seroma (lasting more than three months) | 3 months | volume of seroma aspirated |
Countries
Norway
Outcome results
None listed