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Hematoma is a common complication of alloplastic breast reconstruction. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events.
In this randomized control trial (RCT) assessing TXA use in alloplastic breast reconstruction, one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in alloplastic breast reconstruction reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.
The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease hematoma formation compared to placebo in patients undergoing alloplastic breast reconstruction. This project is designed as a single-center RCT to evaluate the effectiveness of topical TXA in this patient population.
If enrolled in this study, patients individual breasts will be randomly assigned to one of two treatment groups for to apply to the wound before it is closed.
One breast will have an intravenous form of TXA applied topically to the surgical site. The other will be have a topical normal saline solution applied to the wound before closure (a placebo).
The patients will have the standard number of drains and postoperative instructions for breast reconstruction. They will follow-up at two weeks time in clinic for assessment, and emergency room visits will be also be evaluated. Standard of care will be practiced with respect to all procedures and visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic Acid | Experimental | 3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline |
|
| Normal Saline | Placebo Comparator | 40 mL topical of 0.9% normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | 3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma | Incidence rate of hematoma | 2 weeks |
| Seroma | Incidence rate of seroma | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Drain output | Total drain output (mL) at 24 hours | 24 hours |
| Days with drains | Total number of days drains in situ with standard discharge criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Minh Huynh, MD | Contact | 9055221155 | minh.huynh@medportal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ronen Avram, MD, FRCSC | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Healthcare, King Campus | Hamilton | Ontario | L8G 5E4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22611164 | Background | Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054. | |
| 21048170 | Background | Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Randomized Controlled Trial (RCT) with 2 arms: the interventional arm (receiving topical TXA) and the control arm (receiving placebo).
Intervention: Topical application of 3 grams of tranexamic acid (30 mL of 100 mg/mL) diluted in 10 mL of normal saline in the breast.
Placebo: Topical application of 40 mL of 0.9% normal saline to the breast.
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Patients will be randomized on the REDCap system. Their assignment will be made available to research team member, which will be preparing syringes with either TXA or placebo.
| Normal Saline | Drug | 40 mL topical of 0.9% normal saline |
|
|
| 2 weeks |
| Reoperation rate | Number of repeat operations required for patient related to complication | 2 weeks |
| Reintervention rate | Rate of subsequent interventions including aspiration, repeat drain insertion or other | 2 weeks |
| Imaging findings | Ultrasound findings of hematoma or seroma, if applicable | 2 weeks |
| St. Joseph's Healthcare, Charlton Campus | Hamilton | Ontario | L8N 4A6 | Canada |
|
| Juravinski Hospital, Hamilton Health Sciences | Hamilton | Ontario | L8V 1C3 | Canada |
|
| 10694619 | Background | De Bonis M, Cavaliere F, Alessandrini F, Lapenna E, Santarelli F, Moscato U, Schiavello R, Possati GF. Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study. J Thorac Cardiovasc Surg. 2000 Mar;119(3):575-80. doi: 10.1016/s0022-5223(00)70139-5. |
| 22202494 | Background | Ipema HJ, Tanzi MG. Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures. Ann Pharmacother. 2012 Jan;46(1):97-107. doi: 10.1345/aph.1Q383. Epub 2011 Dec 27. |
| 25471907 | Background | Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060. |
| 23541868 | Background | Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on blood loss and transfusion rate in primary total knee arthroplasty. J Arthroplasty. 2013 Aug;28(7):1080-3. doi: 10.1016/j.arth.2012.11.016. Epub 2013 Mar 28. |
| 25450009 | Background | Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23. |
| 31187540 | Background | Knight H, Banks J, Muchmore J, Ives C, Green M. Examining the use of intraoperative tranexamic acid in oncoplastic breast surgery. Breast J. 2019 Sep;25(5):1047-1049. doi: 10.1111/tbj.13409. Epub 2019 Jun 11. No abstract available. |
| 16996422 | Background | Pinsolle V, Grinfeder C, Mathoulin-Pelissier S, Faucher A. Complications analysis of 266 immediate breast reconstructions. J Plast Reconstr Aesthet Surg. 2006;59(10):1017-24. doi: 10.1016/j.bjps.2006.03.057. Epub 2006 Jun 5. |
| 24436188 | Background | Nelson JA, Fischer JP, Grover R, Cleveland E, Erdmann-Sager J, Serletti JM, Wu LC. The impact of anemia on microsurgical breast reconstruction complications and outcomes. Microsurgery. 2014 May;34(4):261-70. doi: 10.1002/micr.22202. Epub 2013 Nov 4. |
| 22689664 | Background | Megson M. Traumatic subcutaneous haematoma causing skin necrosis. BMJ Case Rep. 2011 Jul 20;2011:bcr0520114273. doi: 10.1136/bcr.05.2011.4273. |
| 32243320 | Background | Rogoff H, Marquez JE, Ghosh K, Jou C, McAuliffe P, Rathi S, Monroig K, Medrano C, Marmor WA, Ferrier A, Kapadia K, Klein G, Huston TL, Ganz J, Dagum AB, Khan S, Bui D. Clinical Outcomes After Hematoma Development: A Study of 627 Tissue Expander Breast Reconstructions. Ann Plast Surg. 2020 Jul;85(S1 Suppl 1):S63-S67. doi: 10.1097/SAP.0000000000002343. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |