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Completed

NCT Number: NCT07588828

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ittefaq Hospital Trust

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daflon (Diosmin and Hesperidin)

Drug

Patients received Daflon 500 mg orally twice daily for four weeks after breast cancer surgery.

Primary outcomes

  1. post-operative seroma formation

    Time frame: 8 weeks

    reduction of post-operative seroma formation

Sponsors and collaborators

Lead sponsor

Ittefaq Hospital trust

Other

Registry information

Official study title

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

Acronym: seroma

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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