Clinical trial NCT02627560: The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy
Official title: The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled Double Blinded Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Hemorrhage
Breast Neoplasms
Seroma
Keywords: Administration, topical
Tranexamic acid
Postoperative care
Mastectomy
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Alesund Hospital
First posted: 2015-12-11
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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®

Primary outcomes:
measure: bleeding as defined by drain production per hour the first 24 hours
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Daily drain production up to drain removal - cumulative volume
timeFrame: 3 weeks
measure: number of patients having surgical bleeding in need of re-operation
timeFrame: 3 weeks
measure: number of postoperative aspirations of clinical seroma
timeFrame: up to 3 months
measure: chronic seroma (lasting more than three months)
timeFrame: 3 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs University Hospital
city: Ålesund
country: Norway
facility: Department of Surgery, Aalesund Hospital
Study officials:
affiliation: St. Olavs Hospital
name: Petter Aadahl, MD PhD
role: STUDY_DIRECTOR
affiliation: Ålesund Sykehus
name: Sverrir Olafsson
role: STUDY_DIRECTOR
References:
citation: Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878.
citation: Ausen K, Hagen AI, Ostbyhaug HS, Olafsson S, Kvalsund BJ, Spigset O, Pleym H. Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. BJS Open. 2020 Apr;4(2):216-224. doi: 10.1002/bjs5.50248. Epub 2019 Dec 26.