Seroma Complicating A ProcedurePhase 4SEROMANCT03738527
SEroma Reduction pOst MAstectomy "SEROMA Study"
A Phase 4 study testing Tranexamic Acid 100mg/mL, 20mL topical and Normal Saline Flush, 0.9%, 20mL topical in people with Seroma Complicating A Procedure and Hematoma Postoperative, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
Trial summary
This is a pilot study to evaluate the feasibility of conducting a larger trial to determine if the use of intraoperative topical tranexamic acid (TXA) decreases the rate of post-operative hematomas and seromas in breast cancer patients after their mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Seroma Complicating A Procedure, Hematoma Postoperative, Breast Cancer
- What is being tested?
- Tranexamic Acid 100mg/mL, 20mL topical and Normal Saline Flush, 0.9%, 20mL topical
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 7 Oct 2019to Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer diagnosis
- Age 18-80
- Fluent in English
- Female undergoing mastectomy with or without axillary intervention
Who cannot join
- Immediate reconstruction
- Pre-surgical radiation
- Known allergy to TXA
- Known thromboembolic disease
- High-risk of thromboembolism and/or receiving anticoagulants
- History of myocardial infarction (MI), transient ischemic attack or stroke within the last year
Show all 12Show fewer
- History of subarachnoid hemorrhage
- Premenopausal women with irregular menstrual bleeding of unknown cause
- Acquired disturbances of colour vision
- Hematuria with renal cause
- History of seizure disorder
- Pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
- Recruiting
Juravinski Hospital - Hamilton Health Sciences
Hamilton, Ontario, L8V 1C3
About this study
Official title: Pilot RCT: Use of Tranexamic Acid (TXA) in Post Mastectomy Patients for Seroma and Hematoma Prevention
This is a pilot study to evaluate the feasibility of conducting a larger trial to determine if the use of intraoperative topical tranexamic acid (TXA) decreases the rate of post-operative hematomas and seromas in breast cancer patients after their mastectomy. In other words, the investigators want to determine if applying TXA inside the surgical wound before it is closed helps reduce blood or serous fluid accumulation at the operative site. Dependent on the results of this study, a further larger trial may or may not take place.
Post-operative seromas and hematomas are common complications of mastectomy surgery not only leading to infection, discomfort, wound dehiscence or emergency room visits; they also delay in some instances post-operative adjuvant radiotherapy. Establishing whether or not topical TXA is an effective strategy to decrease those complications can potentially impact positively the breast cancer treatment.
To achieve this aim, this randomized pilot study will first determine whether a larger multicenter study if feasible. This study will replicate a formal randomized trial at a smaller scale in a single center in order to assess the recruitment and randomization process, as well as provide preliminary results for our research question.
Read the detailed description
The objective of this study is to investigate the novel use of topical application of Tranexamic Acid (TXA) to the surgical wound as a means to decrease seroma and/or hematoma formation compared to placebo in post-mastectomy patients. This project is designed as a single-center pilot RCT to evaluate the feasibility of conducting a formal RCT (multicenter trial including more patients) to evaluate the effectiveness of topical TXA.
Patients will be randomly assigned to one of two treatment groups for intraoperative treatment of their mastectomy wound before it is closed.
The first group will consist of those who will be treated with the intravenous form of TXA that will be applied to the surface of the mastectomy wound area rather than being injected into a vein. The second group consists of those individuals who will be treated with a topical normal saline solution (a placebo, or inactive substance that looks identical to the study drug but contains no therapeutic ingredients).
Both groups will receive the same number of drains and the same post-operative follow-up schedule consisting of visits 2 to 4 weeks and 3 months after the surgery, as well as a last 12 months follow-up. Standard of care will be practiced with respect to all procedures and visits.
- Being tested
- Tranexamic Acid 100mg/mL, 20mL topical, Normal Saline Flush, 0.9%, 20mL topical
- Keywords
- tranexamic acid, mastectomy, topical, breast cancer, seroma, hematoma
- Medical subject headings
- Breast Neoplasms, Seroma, Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 100mg/mL, 20mL topicalDrug
Drug: Tranexamic Acid
20 mL TXA (100 mg/mL injection solution, total 2g TXA) applied topically to the mastectomy cavity for 5 minutes before wound closure
Normal Saline Flush, 0.9%, 20mL topicalDrug
Drug: Normal Saline
20 mL 0.9% NaCl (normal saline) applied topically to the mastectomy cavity for 5 minutes before wound closure
| Study group | Role | What they receive |
|---|---|---|
| TXA arm | Experimental | Not described Receives: Drug: Tranexamic Acid 100mg/mL, 20mL topical |
| Placebo arm | Placebo comparator | Not described Receives: Drug: Normal Saline Flush, 0.9%, 20mL topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of patients recruited over the total number of eligible patients screened
Measured: About 6 months
Randomization rate
Number of patients randomized over total number recruited
Measured: About 9 months
Follow-up visit rate
Number of patients with successful follow-up visits at 3 weeks and 3 months
Measured: 3 months
Ability to adhere to protocol
Number of patients randomized to TXA who received TXA vs number of patients randomized to placebo who received the placebo
Measured: About 12 months
Secondary outcomes (4)
Seroma rate
Rate of seroma formation within 3 months following mastectomy in each arm of the study.
Measured: 3 months
Seroma volume
Amount of drainage (volume) in patients who did have a seroma, for patients in both arms of the study
Measured: 3 months
Seroma aspiration
Aspirated volume in patients who did have a seroma, for patients in both arms of the study
Measured: 3 months
Delay in adjuvant treatment
Time (number of weeks) of delay in adjuvant treatment due to seroma/hematoma complication, for patients in both arms of the study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start7 Oct 2019
- Primary completionJan 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Seroma Complicating A ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomized Controlled Trial (RCT) with 2 arms: the interventional arm (receiving topical TXA) and the control arm (receiving placebo). Intervention: Topical application of 20 mL of TXA (100 mg/mL injection solution) to the mastectomy cavity Placebo: Topical application of 20 mL of 0.9% NaCl (normal saline) to the mastectomy cavity
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Hodgson, MD, MSc, FRCSC, Principal investigator, Hamilton Health Sciences, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738527
- Sponsor's protocol ID
- 5271
- Acronym
- SEROMA
- Status last verified
- Feb 2021
- First submitted
- 11 Oct 2018
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Porter KA, O'Connor S, Rimm E, Lopez M. Electrocautery as a factor in seroma formation following mastectomy. Am J Surg. 1998 Jul;176(1):8-11. doi: 10.1016/s0002-9610(98)00093-2.
PubMed 9683123Pogson CJ, Adwani A, Ebbs SR. Seroma following breast cancer surgery. Eur J Surg Oncol. 2003 Nov;29(9):711-7. doi: 10.1016/s0748-7983(03)00096-9.
PubMed 14602488van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.
PubMed 21849243Coveney EC, O'Dwyer PJ, Geraghty JG, O'Higgins NJ. Effect of closing dead space on seroma formation after mastectomy--a prospective randomized clinical trial. Eur J Surg Oncol. 1993 Apr;19(2):143-6.
PubMed 8491318Baker E, Piper J. Drainless mastectomy: Is it safe and effective? Surgeon. 2017 Oct;15(5):267-271. doi: 10.1016/j.surge.2015.12.007. Epub 2016 Feb 19.
PubMed 26907221He XD, Guo ZH, Tian JH, Yang KH, Xie XD. Whether drainage should be used after surgery for breast cancer? A systematic review of randomized controlled trials. Med Oncol. 2011 Dec;28 Suppl 1:S22-30. doi: 10.1007/s12032-010-9673-2. Epub 2010 Sep 9.
PubMed 20827578Ker K, Roberts I, Shakur H, Coats TJ. Antifibrinolytic drugs for acute traumatic injury. Cochrane Database Syst Rev. 2015 May 9;2015(5):CD004896. doi: 10.1002/14651858.CD004896.pub4.
PubMed 25956410Gupta K, Rastogi B, Krishan A, Gupta A, Singh VP, Agarwal S. The prophylactic role of tranexamic acid to reduce blood loss during radical surgery: A prospective study. Anesth Essays Res. 2012 Jan-Jun;6(1):70-3. doi: 10.4103/0259-1162.103378.
PubMed 25885506Perel P, Ker K, Morales Uribe CH, Roberts I. Tranexamic acid for reducing mortality in emergency and urgent surgery. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD010245. doi: 10.1002/14651858.CD010245.pub2.
PubMed 23440847Oertli D, Laffer U, Haberthuer F, Kreuter U, Harder F. Perioperative and postoperative tranexamic acid reduces the local wound complication rate after surgery for breast cancer. Br J Surg. 1994 Jun;81(6):856-9. doi: 10.1002/bjs.1800810621.
PubMed 8044602Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD010562. doi: 10.1002/14651858.CD010562.pub2.
PubMed 23881695Xu X, Xiong S, Wang Z, Li X, Liu W. Topical administration of tranexamic acid in total hip arthroplasty: A meta-analysis of Randomized Controlled Trials. Drug Discov Ther. 2015 Jun;9(3):173-7. doi: 10.5582/ddt.2015.01018.
PubMed 26193938Ausen 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.
PubMed 26349843Bennett C, Klingenberg SL, Langholz E, Gluud LL. Tranexamic acid for upper gastrointestinal bleeding. Cochrane Database Syst Rev. 2014 Nov 21;2014(11):CD006640. doi: 10.1002/14651858.CD006640.pub3.
PubMed 25414987
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT: Use of Tranexamic Acid (TXA) in Post Mastectomy Patients for Seroma and Hematoma Prevention
- ClinicalTrials.gov ID
- NCT03738527
- Acronym / sponsor ID
- SEROMA / 5271
- Keywords
- tranexamic acid, mastectomy, topical, breast cancer, seroma, hematoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to evaluate the feasibility of conducting a larger trial to determine if the use of intraoperative topical tranexamic acid (TXA) decreases the rate of post-operative hematomas and seromas in breast cancer patients after their mastectomy. In other words, the investigators want to determine if applying TXA inside the surgical wound before it is closed helps reduce blood or serous fluid accumulation at the operative site. Dependent on the results of this study, a further larger trial may or may not take place.
Post-operative seromas and hematomas are common complications of mastectomy surgery not only leading to infection, discomfort, wound dehiscence or emergency room visits; they also delay in some instances post-operative adjuvant radiotherapy. Establishing whether or not topical TXA is an effective strategy to decrease those complications can potentially impact positively the breast cancer treatment.
To achieve this aim, this randomized pilot study will first determine whether a larger multicenter study if feasible. This study will replicate a formal randomized trial at a smaller scale in a single center in order to assess the recruitment and randomization process, as well as provide preliminary results for our research question.
Detailed description
The objective of this study is to investigate the novel use of topical application of Tranexamic Acid (TXA) to the surgical wound as a means to decrease seroma and/or hematoma formation compared to placebo in post-mastectomy patients. This project is designed as a single-center pilot RCT to evaluate the feasibility of conducting a formal RCT (multicenter trial including more patients) to evaluate the effectiveness of topical TXA.
Patients will be randomly assigned to one of two treatment groups for intraoperative treatment of their mastectomy wound before it is closed.
The first group will consist of those who will be treated with the intravenous form of TXA that will be applied to the surface of the mastectomy wound area rather than being injected into a vein. The second group consists of those individuals who will be treated with a topical normal saline solution (a placebo, or inactive substance that looks identical to the study drug but contains no therapeutic ingredients).
Both groups will receive the same number of drains and the same post-operative follow-up schedule consisting of visits 2 to 4 weeks and 3 months after the surgery, as well as a last 12 months follow-up. Standard of care will be practiced with respect to all procedures and visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Pilot Randomized Controlled Trial (RCT) with 2 arms: the interventional arm (receiving topical TXA) and the control arm (receiving placebo). Intervention: Topical application of 20 mL of TXA (100 mg/mL injection solution) to the mastectomy cavity Placebo: Topical application of 20 mL of 0.9% NaCl (normal saline) to the mastectomy cavity
| Arm | Type | Receives |
|---|---|---|
| TXA arm | Experimental | Drug: Tranexamic Acid 100mg/mL, 20mL topical |
| Placebo arm | Placebo comparator | Drug: Normal Saline Flush, 0.9%, 20mL topical |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast cancer diagnosis
- Age 18-80
- Fluent in English
- Female undergoing mastectomy with or without axillary intervention
Key exclusion criteria (12 listed)
- Immediate reconstruction
- Pre-surgical radiation
- Known allergy to TXA
- Known thromboembolic disease
- High-risk of thromboembolism and/or receiving anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid 100mg/mL, 20mL topicalDrug: Tranexamic Acid 20 mL TXA (100 mg/mL injection solution, total 2g TXA) applied topically to the mastectomy cavity for 5 minutes before wound closure | Drug | TXA arm |
| Normal Saline Flush, 0.9%, 20mL topicalDrug: Normal Saline 20 mL 0.9% NaCl (normal saline) applied topically to the mastectomy cavity for 5 minutes before wound closure | Drug | Placebo arm |
Primary outcome
Recruitment rate
Time frame: About 6 months
Number of patients recruited over the total number of eligible patients screened
Randomization rate
Time frame: About 9 months
Number of patients randomized over total number recruited
Follow-up visit rate
Time frame: 3 months
Number of patients with successful follow-up visits at 3 weeks and 3 months
Ability to adhere to protocol
Time frame: About 12 months
Number of patients randomized to TXA who received TXA vs number of patients randomized to placebo who received the placebo
4 secondary outcomes
Seroma rate
Time frame: 3 months
Seroma volume
Time frame: 3 months
Seroma aspiration
Time frame: 3 months
Delay in adjuvant treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 9683123Porter KA, O'Connor S, Rimm E, Lopez M. Electrocautery as a factor in seroma formation following mastectomy. Am J Surg. 1998 Jul;176(1):8-11. doi: 10.1016/s0002-9610(98)00093-2.
- Background: PubMed 14602488Pogson CJ, Adwani A, Ebbs SR. Seroma following breast cancer surgery. Eur J Surg Oncol. 2003 Nov;29(9):711-7. doi: 10.1016/s0748-7983(03)00096-9.
- Background: PubMed 21849243van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.
- Background: PubMed 8491318Coveney EC, O'Dwyer PJ, Geraghty JG, O'Higgins NJ. Effect of closing dead space on seroma formation after mastectomy--a prospective randomized clinical trial. Eur J Surg Oncol. 1993 Apr;19(2):143-6.
- Background: PubMed 26907221Baker E, Piper J. Drainless mastectomy: Is it safe and effective? Surgeon. 2017 Oct;15(5):267-271. doi: 10.1016/j.surge.2015.12.007. Epub 2016 Feb 19.
- Background: PubMed 20827578He XD, Guo ZH, Tian JH, Yang KH, Xie XD. Whether drainage should be used after surgery for breast cancer? A systematic review of randomized controlled trials. Med Oncol. 2011 Dec;28 Suppl 1:S22-30. doi: 10.1007/s12032-010-9673-2. Epub 2010 Sep 9.
- Background: PubMed 25956410Ker K, Roberts I, Shakur H, Coats TJ. Antifibrinolytic drugs for acute traumatic injury. Cochrane Database Syst Rev. 2015 May 9;2015(5):CD004896. doi: 10.1002/14651858.CD004896.pub4.
- Background: PubMed 25885506Gupta K, Rastogi B, Krishan A, Gupta A, Singh VP, Agarwal S. The prophylactic role of tranexamic acid to reduce blood loss during radical surgery: A prospective study. Anesth Essays Res. 2012 Jan-Jun;6(1):70-3. doi: 10.4103/0259-1162.103378.
- Background: PubMed 23440847Perel P, Ker K, Morales Uribe CH, Roberts I. Tranexamic acid for reducing mortality in emergency and urgent surgery. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD010245. doi: 10.1002/14651858.CD010245.pub2.
- Background: PubMed 8044602Oertli D, Laffer U, Haberthuer F, Kreuter U, Harder F. Perioperative and postoperative tranexamic acid reduces the local wound complication rate after surgery for breast cancer. Br J Surg. 1994 Jun;81(6):856-9. doi: 10.1002/bjs.1800810621.
- Background: PubMed 23881695Ker K, Beecher D, Roberts I. Topical application of tranexamic acid for the reduction of bleeding. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD010562. doi: 10.1002/14651858.CD010562.pub2.
- Background: PubMed 26193938Xu X, Xiong S, Wang Z, Li X, Liu W. Topical administration of tranexamic acid in total hip arthroplasty: A meta-analysis of Randomized Controlled Trials. Drug Discov Ther. 2015 Jun;9(3):173-7. doi: 10.5582/ddt.2015.01018.
- Individual participant dataSharing planned: No
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Recruiting
Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery
Parotid Neoplasms, Post-operative Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Hodgson, MD, MSc, FRCSC principal investigator
Hamilton Health Sciences, McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid 100mg/mL, 20mL topical and Normal Saline Flush, 0.9%, 20mL topical in people with Seroma Complicating A Procedure and Hematoma Postoperative, run by Hamilton Health Sciences Corporation at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Duchesnay, M.D. (905-521-2100 ext. #4843, isabelle.duchesnay@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: About 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738527, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.