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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003160-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Alesund Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| topical tranexamic acid | Experimental | tranexamic acid to be smeared on surgical wounds before closure |
|
| placebo control | Placebo Comparator | saline to be smeared on surgical wounds before closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petter Aadahl, MD PhD | St. Olavs Hospital | Study Director |
| Sverrir Olafsson | Ã…lesund Sykehus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Aalesund Hospital | Ã…lesund | Norway | ||||
| St Olavs University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26349843 | Background | 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. | |
| 32207575 | Result | 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. |
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| ID | Term |
|---|---|
| D019106 | Postoperative Hemorrhage |
| D001943 | Breast Neoplasms |
| D049291 | Seroma |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| saline | Drug | moisten the surgical wound surface with 20 ml placebo (0.9% saline) |
|
| up to 3 months |
| chronic seroma (lasting more than three months) | volume of seroma aspirated | 3 months |
| Trondheim |
| 7006 |
| Norway |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |