EFFECT OF DAFLON (DIOSMIN AND HESPERIDIN) ON POST-OPERATIVE SEROMA FORMATION IN BREAST CANCER SURGERY'' (seroma)

May 13, 2026 updated by: Amna Arshad, Ittefaq Hospital trust

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

190

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Ittefaq Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Drug: Daflon (Diosmin and Hesperidin)
Patients received Daflon 500 mg orally twice daily for four weeks after breast cancer surgery.
No Intervention: Control group
Control group did not receive Daflon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative seroma formation
Time Frame: 8 weeks
reduction of post-operative seroma formation
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ittefaq Hospital trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

February 28, 2026

Study Completion (Actual)

April 15, 2026

Study Registration Dates

First Submitted

May 7, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IttefaqH
  • AArshad (Other Identifier: IttefaqH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared due to institutional data protection policies and participant confidentiality considerations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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