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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
202
moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
moisten the surgical wound surface with 20 ml placebo (0.9% saline)
Department of Surgery, Aalesund Hospital
Ålesund, Norway
St Olavs University Hospital
Trondheim, Norway
bleeding as defined by drain production per hour the first 24 hours
Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml
Time frame: 24 hours postoperatively
Daily drain production up to drain removal - cumulative volume
Time frame: 3 weeks
number of patients having surgical bleeding in need of re-operation
Time frame: 3 weeks
number of postoperative aspirations of clinical seroma
Time frame: up to 3 months
chronic seroma (lasting more than three months)
volume of seroma aspirated
Time frame: 3 months
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