EFFECT OF TOPICAL APPLICATION OF TRANEXAMIC ACID ON WOUND DRAINAGE POST MODIFIED RADICAL MASTECTOMYNCT07800832
EFFECT OF TOPICAL APPLICATION OF TRANEXAMIC ACID ON WOUND DRAINAGE POST MODIFIED RADICAL MASTECTOMY
A study testing Tranexamic Acid (Topical Application in Mastectomy Wound) in people with EFFECT OF TOPICAL APPLICATION OF TRANEXAMIC ACID ON WOUND DRAINAGE POST MODIFIED RADICAL MASTECTOMY, run by Gulab Devi Hospital at 2 sites in Pakistan.
Trial summary
Objective: To compare efficacy of topical tranexamic acid versus standard postop care in reducing wound drainage following modified radical mastectomy (MRM). Study Design: Randomized controlled trial. Setting and Duration: Department of General Surgery, Gulab Devi Hospital, over period of six months. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- EFFECT OF TOPICAL APPLICATION OF TRANEXAMIC ACID ON WOUND DRAINAGE POST MODIFIED RADICAL MASTECTOMY
- What is being tested?
- Tranexamic Acid (Topical Application in Mastectomy Wound)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPakistan
- Study dates
- 3 Sep 2025to 10 Mar 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. All patients diagnosed with ductal or lobular breast carcinoma for whom MRM is indicated.
Who cannot join
- History of thromboembolic events.
- Patients with coagulation disorders.
- Currently on anticoagulant therapy.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Gulab Devi Educational
Lahore, Punjab Province
Gulab Devi hospital
Lahore, Punjab Province
About this study
Objective: To compare efficacy of topical tranexamic acid versus standard postop care in reducing wound drainage following modified radical mastectomy (MRM).
Study Design: Randomized controlled trial. Setting and Duration: Department of General Surgery, Gulab Devi Hospital, over period of six months.
Methods: Total of 60 patients undergoing MRM were enrolled and randomly allocated into two groups, with 30 patients in each group. Group I received topical tranexamic acid applied to surgical wound, while Group II received standard postop care without tranexamic acid. Objective was to assess total wound drainage ( in ml), duration of drainage (in days) and frequency of wound infection among two group. Data were analyzed using SPSS version 26, and p-value ≤0.05 was considered statistically significant.
- Conditions
- EFFECT OF TOPICAL APPLICATION OF TRANEXAMIC ACID ON WOUND DRAINAGE POST MODIFIED RADICAL MASTECTOMY
- Being tested
- Tranexamic Acid (Topical Application in Mastectomy Wound)
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
TRANEXAMIC acid topical application
| Study group | Role | What they receive |
|---|---|---|
| Patients given TRANEXAMIC acid | Experimental | Patients given TRANEXAMIC acid Receives: Drug: Tranexamic Acid (Topical Application in Mastectomy Wound) |
| Patients not given TRANEXAMIC acid | No intervention | Patients not given TRANEXAMIC acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound drainage
To compare efficacy of topical application of tranexamic acid compared to standard postoperative care after MRM in terms of duration of wound drainage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start3 Sep 2025
- Primary completion8 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EFFECT OF TOPICAL APPLICATION OF TRANEXAMIC ACID ON WOUND DRAINAGE POST MODIFIED RADICAL MASTECTOMYStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulab Devi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rida Aamir, Gulab Devi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800832
- Sponsor's protocol ID
- AAMC/IRB/EA/39/2025
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF TOPICAL APPLICATION OF TRANEXAMIC ACID ON WOUND DRAINAGE POST MODIFIED RADICAL MASTECTOMY
- ClinicalTrials.gov ID
- NCT07800832
- Acronym / sponsor ID
- AAMC/IRB/EA/39/2025
- Conditions
- EFFECT OF TOPICAL APPLICATION OF TRANEXAMIC ACID ON WOUND DRAINAGE POST MODIFIED RADICAL MASTECTOMY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gulab Devi HospitalUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 8 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 2 Sep 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.
Objective: To compare efficacy of topical tranexamic acid versus standard postop care in reducing wound drainage following modified radical mastectomy (MRM).
Study Design: Randomized controlled trial. Setting and Duration: Department of General Surgery, Gulab Devi Hospital, over period of six months.
Methods: Total of 60 patients undergoing MRM were enrolled and randomly allocated into two groups, with 30 patients in each group. Group I received topical tranexamic acid applied to surgical wound, while Group II received standard postop care without tranexamic acid. Objective was to assess total wound drainage ( in ml), duration of drainage (in days) and frequency of wound infection among two group. Data were analyzed using SPSS version 26, and p-value ≤0.05 was considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients given TRANEXAMIC acid | Experimental | Drug: Tranexamic Acid (Topical Application in Mastectomy Wound)Patients given TRANEXAMIC acid |
| Patients not given TRANEXAMIC acid | No intervention | –Patients not given TRANEXAMIC acid |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. All patients diagnosed with ductal or lobular breast carcinoma for whom MRM is indicated.
Key exclusion criteria (3 listed)
- History of thromboembolic events.
- Patients with coagulation disorders.
- Currently on anticoagulant therapy.
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)TRANEXAMIC acid topical application | Drug | Patients given TRANEXAMIC acid |
Primary outcome
Wound drainage
Time frame: 6 months
To compare efficacy of topical application of tranexamic acid compared to standard postoperative care after MRM in terms of duration of wound drainage
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 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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) in people with EFFECT OF TOPICAL APPLICATION OF TRANEXAMIC ACID ON WOUND DRAINAGE POST MODIFIED RADICAL MASTECTOMY, run by Gulab Devi Hospital at 2 sites 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 1 inclusion and 3 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 2 Sep 2026. 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 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?
Wound drainage (time frame: 6 months). 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 2 Sep 2026.