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

NCT07588828 | Completed Phase 4

• 2 other identifiers: IttefaqHAArshad
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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 cancer surgery with sentinel lymph node biopsy or axillary lymph node dissection.

Conditions

Post-operative Seroma Formation; Breast Cancer Surgery

Outcome Measures

Primary Outcomes (1)

• post-operative seroma formation

  reduction of post-operative seroma formation

  8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Drug: Daflon (Diosmin and Hesperidin)

Control group

NO INTERVENTION

Control group did not receive Daflon.

Interventions

Daflon (Diosmin and Hesperidin) DRUG

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ittefaq Hospital trust: lead

Study Sites (1)

Ittefaq Hospital Trust

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 36572609 BACKGROUND

MeSH Terms

Interventions

Diosmin; Hesperidin

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavanones; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 15, 2026
• Study Start: October 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: April 15, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)