Post-operative Seroma FormationPhase 4seromaNCT07588828
EFFECT OF DAFLON (DIOSMIN AND HESPERIDIN) ON POST-OPERATIVE SEROMA FORMATION IN BREAST CANCER SURGERY''
A Phase 4 study testing Daflon (Diosmin and Hesperidin) in people with Post-operative Seroma Formation and Breast Cancer Surgery, run by Ittefaq Hospital trust at 1 site in Pakistan.
Trial summary
Post-operative seroma formation remains one of the most common complications following breast cancer surgery. This prospective randomized controlled trial was conducted to evaluate the efficacy of Micronized Purified Flavonoid Fraction (Daflon) in reducing post-operative seroma formation in patients undergoing breast… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Seroma Formation, Breast Cancer Surgery
- What is being tested?
- Daflon (Diosmin and Hesperidin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 15 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing breast cancer surgery, including either breast-conserving surgery or mastectomy with sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND), during the study period were included
Who cannot join
- Patients were excluded if they had pre-existing disease-related upper limb lymphedema, had undergone extensive oncoplastic procedures such as latissimus dorsi myocutaneaous flap (LDMF) or deep inferior epigastric perforator (DIEP) flap reconstruction, had a previously irradiated breast, or underwent only wide local excision under local anaesthesia in the setting of American Society of Anaesthesiologists (ASA) class IV or higher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF DAFLON (DIOSMIN AND HESPERIDIN) ON POST-OPERATIVE SEROMA FORMATION IN BREAST CANCER SURGERY
Post-operative seroma formation remains one of the most common complications following breast cancer surgery. This prospective randomized controlled trial was conducted to evaluate the efficacy of Micronized Purified Flavonoid Fraction (Daflon) in reducing post-operative seroma formation in patients undergoing breast cancer surgery with sentinel lymph node biopsy or axillary lymph node dissection.
Read the detailed description
This single-center prospective randomized controlled study was conducted at the Breast Surgery Unit, Ittefaq Hospital Trust, Lahore. Female patients undergoing breast-conserving surgery or mastectomy with sentinel lymph node biopsy or axillary lymph node dissection for breast cancer were included. Participants were randomized into intervention and control groups according to surgical procedure strata. The intervention arm received Daflon 500 mg twice daily for four weeks post-operatively. Outcomes included seroma formation, drain output, and drain removal duration.
- Being tested
- Daflon (Diosmin and Hesperidin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daflon (Diosmin and Hesperidin)Drug
Patients received Daflon 500 mg orally twice daily for four weeks after breast cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Drug: Daflon (Diosmin and Hesperidin) |
| Control group | No intervention | Control group did not receive Daflon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative seroma formation
reduction of post-operative seroma formation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Oct 2024
- Primary completion28 Feb 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative Seroma FormationStudies 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
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ittefaq Hospital trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amna Arshad, Ittefaq Hospital trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588828
- Sponsor's protocol ID
- IttefaqH
- Other IDs
- AArshad
- Acronym
- seroma
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to institutional data protection policies and participant confidentiality considerations
Publications
Calpin GG, McAnena PF, Davey MG, Calpin P, Kerin MJ, McInerney N, Walsh SR, Lowery AJ. The role of tranexamic acid in reducing post-operative bleeding and seroma formation in breast surgery: A meta-analysis. Surgeon. 2023 Aug;21(4):e183-e194. doi: 10.1016/j.surge.2022.11.005. Epub 2022 Dec 24.
PubMed 36572609
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF DAFLON (DIOSMIN AND HESPERIDIN) ON POST-OPERATIVE SEROMA FORMATION IN BREAST CANCER SURGERY
- ClinicalTrials.gov ID
- NCT07588828
- Acronym / sponsor ID
- seroma / IttefaqH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Ittefaq Hospital trustUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 15 May 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.
Post-operative seroma formation remains one of the most common complications following breast cancer surgery. This prospective randomized controlled trial was conducted to evaluate the efficacy of Micronized Purified Flavonoid Fraction (Daflon) in reducing post-operative seroma formation in patients undergoing breast cancer surgery with sentinel lymph node biopsy or axillary lymph node dissection.
Detailed description
This single-center prospective randomized controlled study was conducted at the Breast Surgery Unit, Ittefaq Hospital Trust, Lahore. Female patients undergoing breast-conserving surgery or mastectomy with sentinel lymph node biopsy or axillary lymph node dissection for breast cancer were included. Participants were randomized into intervention and control groups according to surgical procedure strata. The intervention arm received Daflon 500 mg twice daily for four weeks post-operatively. Outcomes included seroma formation, drain output, and drain removal duration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Daflon (Diosmin and Hesperidin) |
| Control group | No intervention | –Control group did not receive Daflon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing breast cancer surgery, including either breast-conserving surgery or mastectomy with sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND), during the study period were included
Key exclusion criteria (1 listed)
- Patients were excluded if they had pre-existing disease-related upper limb lymphedema, had undergone extensive oncoplastic procedures such as latissimus dorsi myocutaneaous flap (LDMF) or deep inferior epigastric perforator (DIEP) flap reconstruction, had a previously irradiated breast, or underwent only wide local excision under local anaesthesia in the setting of American Society of Anaesthesiologists (ASA) class IV or higher.
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 |
|---|---|---|
| Daflon (Diosmin and Hesperidin)Patients received Daflon 500 mg orally twice daily for four weeks after breast cancer surgery. | Drug | Intervention group |
Primary outcome
post-operative seroma formation
Time frame: 8 weeks
reduction of post-operative seroma formation
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 15 May 2026.
- Background: PubMed 36572609Calpin GG, McAnena PF, Davey MG, Calpin P, Kerin MJ, McInerney N, Walsh SR, Lowery AJ. The role of tranexamic acid in reducing post-operative bleeding and seroma formation in breast surgery: A meta-analysis. Surgeon. 2023 Aug;21(4):e183-e194. doi: 10.1016/j.surge.2022.11.005. Epub 2022 Dec 24.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to institutional data protection policies and participant confidentiality considerations
Related trials for Post-operative Seroma Formation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Daflon (Diosmin and Hesperidin) in people with Post-operative Seroma Formation and Breast Cancer Surgery, run by Ittefaq Hospital trust 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 1 inclusion and 1 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 15 May 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.
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?
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?
post-operative seroma formation (time frame: 8 weeks). 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 NCT07588828, which also lists 1 linked publication.
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 15 May 2026.