Breast Cancer FemalesNCT07434453
"Topical Tranexamic Acid With Flap Fixation: A Novel Approach to Minimize Post-operative Drainage and Surgical Site Infection in Patients Undergoing Modified Radical Mastectomy"
A study testing Tranexamic Acid (Topical Application in Mastectomy Wound) and flap fixation in people with Breast Cancer Females, run by Noor ul Ain at 1 site in Pakistan.
Trial summary
Seroma (a collection of fluid under the skin) is a common problem after breast cancer surgery, especially after modified radical mastectomy (MRM), where lymph nodes from the armpit are also removed. This can happen because surgery may damage small blood and lymph vessels. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Females
- What is being tested?
- Tranexamic Acid (Topical Application in Mastectomy Wound) and flap fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Aug 2023to 30 Aug 2024
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all females.
- Age more than 18 Years
Who cannot join
- high risk of thromboembolism requiring anti-coagulant in perioperative period
- known allergy to Tranexamic acid documented in history
- patients requiring delayed wound closure after MRM
- wound edge necrosis documented on examination postoperatively
- preoperative involvement of muscle and bone and less than R0 resection.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
king Edward medical university/mayo hospital lahore
Lahore, Punjab Province, 54000
About this study
Seroma (a collection of fluid under the skin) is a common problem after breast cancer surgery, especially after modified radical mastectomy (MRM), where lymph nodes from the armpit are also removed. This can happen because surgery may damage small blood and lymph vessels. Doctors use different methods to reduce this fluid buildup, such as special glues, drains, and stitching techniques, but results are not always the same.
Tranexamic acid (TXA) is an affordable medicine that can help reduce bleeding, bruising, and fluid collection after surgery. A study at Mayo Hospital (2023-2024) looked at whether applying TXA directly to the surgical wound, along with a stitching method called flap fixation, could improve healing after breast cancer surgery.
Read more
In this study, 62 patients were divided into two groups. One group received TXA in the wound plus flap fixation, while the other group had flap fixation only. Researchers compared wound infection rates and the amount of fluid collected after surgery.
The results showed that using TXA with flap fixation significantly reduced fluid collection (seroma) and wound infection. This method is safe, simple, and cost-effective, and may help improve recovery for patients undergoing breast cancer surgery.
Read the detailed description
Seroma is invariably associated with breast cancer surgery and is a recurring, problematic issue that has affected large number of patients. MRM in patients having locally advanced breast cancer has raised serious questions about the methods of prevention and management of subsequent seroma as axillary dissection is a strong risk factor for seroma formation, most likely damaging blood and lymphatic vessels. Various methods like topical fibrin sealants, suction drainage and quilting have been used to reduce its incidence with variable outcomes. Topical tranexamic acid (TXA) was demonstrated as a unique and inexpensive pharmacologic agent capable of decreasing blood loss, hematoma, seroma, and bruising among various general surgical and reconstructive procedures.
A study was conducted to assess the impact of applying tranexamic acid topically in combination with flap fixation on wound outcomes in patients undergoing MRM for breast cancer, focusing on the incidence of surgical site infections and the volume of postoperative drainage on surgical floor, of Mayo Hospital from 2023 to 2024.
After taking approval from ethical committee a total of 62 patients were selected as per inclusion criteria. The patients were randomized into two groups i.e. Group A patients underwent topical application of tranexamic acid along with flap fixation in mastectomy wound. While in group B patients, mastectomy wound was closed without topical application of tranexamic acid with flap fixation.
Data was entered in SPSS 26 version. Comparative analysis of two groups, Group A (with topical tranexamic acid application along with Flap Fixation) and Group B (without topical tranexamic acid application along with Flap Fixation) was done by applying chi-square test for wound infection and independent t-test for drain volume. P value <0.05 will be considered important.
Topical application of tranexamic acid, along with flap fixation has been found to decrease seroma formation and surgical site infection to a significant extent. Not only is this technique cost-effective but it is also easily applicable in patients with breast cancer who are scheduled to undergo MRM.
- Conditions
- Breast Cancer Females
- Being tested
- Tranexamic Acid (Topical Application in Mastectomy Wound), flap fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (Topical Application in Mastectomy Wound)Drug
Participants undergoing modified radical mastectomy (MRM) for breast cancer were randomized into two groups. In the experimental group, tranexamic acid (TXA) was applied topically to the mastectomy wound at the time of surgical closure, in addition to flap fixation. In the control group, wound closure was performed with flap fixation alone, without topical tranexamic acid.
Both groups received standard perioperative surgical care according to institutional practice. Postoperative outcomes assessed included seroma formation, total drain output, and surgical site infection during the follow-up period
flap fixationProcedure or surgery
Participants undergoing modified radical mastectomy (MRM) receive standard wound closure with flap fixation without topical tranexamic acid. Postoperative outcomes assessed include seroma formation, total drain output, and surgical site infection up to the 30th postoperative day.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Received topical tranexamic acid (TXA) along with flap fixation. | Experimental | Arm 1 - Experimental Arm:
Participants undergoing modified radical mastectomy (MRM) received topical tranexamic acid (TXA) applied to the surgical wound along with flap fixation at the time of wound closure to reduce postoperative seroma formation, drainage volume, and surgical site infection. Receives: Drug: Tranexamic Acid (Topical Application in Mastectomy Wound) |
| Arm 2: Active Comparator - Flap Fixation Only | Active comparator | Participants undergoing modified radical mastectomy (MRM) receive standard wound closure with flap fixation without topical tranexamic acid. Postoperative outcomes assessed include seroma formation, total drain output, and surgical site infection up to the 30th postoperative day. Receives: Procedure: flap fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Drain Output
Total volume of fluid collected from the surgical drain following modified radical mastectomy. Drain output was measured in millilitres (mL) using calibrated closed suction drainage containers placed at the operative site. The cumulative volume recorded was documented for each participant.
Measured: Measured from the day of surgery until drain removal days after surgery.
Secondary outcomes (2)
Incidence of Surgical Site Infection
Occurrence of surgical site infection within 30 days after surgery. Surgical site infection was diagnosed based on clinical criteria including purulent discharge from the wound, erythema, local warmth, swelling, pain, or wound dehiscence requiring antibiotic therapy. it is measured in percentage.
Measured: Within 30 days postoperatively
Incidence of Postoperative Seroma Formation
Postoperative seroma formation was defined as the accumulation of clinically detectable serous fluid at the mastectomy or axillary surgical site after drain removal. Diagnosis was made based on clinical examination showing localized swelling or fluctuation at the operative site, confirmed by aspiration of serous fluid when required. Cases requiring needle aspiration were recorded as seroma. The incidence was calculated as the proportion of participants who developed seroma among the total number of participants in each group.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start4 Aug 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemalesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noor ul Ain
- Sponsor type
- University, hospital or other
- Collaborators
- King Edward Medical University
- Responsible party
- Sponsor-investigator, Noor ul Ain, King Edward Medical University
- Investigators
- noor-ul-ain mujahid, FCPS(general surgery), Principal investigator, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434453
- Sponsor's protocol ID
- 705/RC/KEMU
- Status last verified
- Aug 2024
- First submitted
- 11 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made publicly available. However, summary results may be shared through scientific publications or presentations while maintaining participant confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Topical Tranexamic Acid With Flap Fixation: A Novel Approach to Minimize Post-operative Drainage and Surgical Site Infection in Patients Undergoing Modified Radical Mastectomy"
- ClinicalTrials.gov ID
- NCT07434453
- Acronym / sponsor ID
- 705/RC/KEMU
- Conditions
- Breast Cancer Females
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Noor ul AinUniversity, hospital or other
- Collaborators
- King Edward Medical University
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 25 Feb 2026 (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.
Seroma (a collection of fluid under the skin) is a common problem after breast cancer surgery, especially after modified radical mastectomy (MRM), where lymph nodes from the armpit are also removed. This can happen because surgery may damage small blood and lymph vessels. Doctors use different methods to reduce this fluid buildup, such as special glues, drains, and stitching techniques, but results are not always the same.
Tranexamic acid (TXA) is an affordable medicine that can help reduce bleeding, bruising, and fluid collection after surgery. A study at Mayo Hospital (2023-2024) looked at whether applying TXA directly to the surgical wound, along with a stitching method called flap fixation, could improve healing after breast cancer surgery.
In this study, 62 patients were divided into two groups. One group received TXA in the wound plus flap fixation, while the other group had flap fixation only. Researchers compared wound infection rates and the amount of fluid collected after surgery.
The results showed that using TXA with flap fixation significantly reduced fluid collection (seroma) and wound infection. This method is safe, simple, and cost-effective, and may help improve recovery for patients undergoing breast cancer surgery.
Detailed description
Seroma is invariably associated with breast cancer surgery and is a recurring, problematic issue that has affected large number of patients. MRM in patients having locally advanced breast cancer has raised serious questions about the methods of prevention and management of subsequent seroma as axillary dissection is a strong risk factor for seroma formation, most likely damaging blood and lymphatic vessels. Various methods like topical fibrin sealants, suction drainage and quilting have been used to reduce its incidence with variable outcomes. Topical tranexamic acid (TXA) was demonstrated as a unique and inexpensive pharmacologic agent capable of decreasing blood loss, hematoma, seroma, and bruising among various general surgical and reconstructive procedures.
A study was conducted to assess the impact of applying tranexamic acid topically in combination with flap fixation on wound outcomes in patients undergoing MRM for breast cancer, focusing on the incidence of surgical site infections and the volume of postoperative drainage on surgical floor, of Mayo Hospital from 2023 to 2024.
After taking approval from ethical committee a total of 62 patients were selected as per inclusion criteria. The patients were randomized into two groups i.e. Group A patients underwent topical application of tranexamic acid along with flap fixation in mastectomy wound. While in group B patients, mastectomy wound was closed without topical application of tranexamic acid with flap fixation.
Data was entered in SPSS 26 version. Comparative analysis of two groups, Group A (with topical tranexamic acid application along with Flap Fixation) and Group B (without topical tranexamic acid application along with Flap Fixation) was done by applying chi-square test for wound infection and independent t-test for drain volume. P value <0.05 will be considered important.
Topical application of tranexamic acid, along with flap fixation has been found to decrease seroma formation and surgical site infection to a significant extent. Not only is this technique cost-effective but it is also easily applicable in patients with breast cancer who are scheduled to undergo MRM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Received topical tranexamic acid (TXA) along with flap fixation. | Experimental | Drug: Tranexamic Acid (Topical Application in Mastectomy Wound)Arm 1 - Experimental Arm: Participants undergoing modified radical mastectomy (MRM) received topical tranexamic acid (TXA) applied to the surgical wound along with flap fixation at the time of wound closure to reduce postoperative seroma formation, drainage volume, and surgical site infection. |
| Arm 2: Active Comparator - Flap Fixation Only | Active comparator | Procedure: flap fixationParticipants undergoing modified radical mastectomy (MRM) receive standard wound closure with flap fixation without topical tranexamic acid. Postoperative outcomes assessed include seroma formation, total drain output, and surgical site infection up to the 30th postoperative day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all females.
- Age more than 18 Years
Key exclusion criteria (5 listed)
- high risk of thromboembolism requiring anti-coagulant in perioperative period
- known allergy to Tranexamic acid documented in history
- patients requiring delayed wound closure after MRM
- wound edge necrosis documented on examination postoperatively
- preoperative involvement of muscle and bone and less than R0 resection.
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 (Topical Application in Mastectomy Wound)Participants undergoing modified radical mastectomy (MRM) for breast cancer were randomized into two groups. In the experimental group, tranexamic acid (TXA) was applied topically to the mastectomy wound at the time of surgical closure, in addition to flap fixation. In the control group, wound closure was performed with flap fixation alone, without topical tranexamic acid. Both groups received standard perioperative surgical care according to institutional practice. Postoperative outcomes assessed included seroma formation, total drain output, and surgical site infection during the follow-up period | Drug | Group A: Received topical tranexamic acid (TXA) along with flap fixation. |
| flap fixationParticipants undergoing modified radical mastectomy (MRM) receive standard wound closure with flap fixation without topical tranexamic acid. Postoperative outcomes assessed include seroma formation, total drain output, and surgical site infection up to the 30th postoperative day. | Procedure or surgery | Arm 2: Active Comparator - Flap Fixation Only |
Primary outcome
Total Postoperative Drain Output
Time frame: Measured from the day of surgery until drain removal days after surgery.
Total volume of fluid collected from the surgical drain following modified radical mastectomy. Drain output was measured in millilitres (mL) using calibrated closed suction drainage containers placed at the operative site. The cumulative volume recorded was documented for each participant.
2 secondary outcomes
Incidence of Surgical Site Infection
Time frame: Within 30 days postoperatively
Incidence of Postoperative Seroma Formation
Time frame: Within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made publicly available. However, summary results may be shared through scientific publications or presentations while maintaining participant confidentiality
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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.
noor-ul-ain mujahid, FCPS(general surgery) principal investigator
King Edward Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid (Topical Application in Mastectomy Wound) and flap fixation in people with Breast Cancer Females, run by Noor ul Ain at 1 site in Pakistan.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Postoperative Drain Output (time frame: Measured from the day of surgery until drain removal days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026.