Clinical trial · Interventional
EFFECT OF DAFLON (DIOSMIN AND HESPERIDIN) ON POST-OPERATIVE SEROMA FORMATION IN BREAST CANCER SURGERY''
EFFECT OF DAFLON (DIOSMIN AND HESPERIDIN) ON POST-OPERATIVE SEROMA FORMATION IN BREAST CANCER SURGERY
NCT07588828CI-TRIAL-00111778seromacompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Surgery | — | UNRESOLVED | — |
| Post-operative Seroma Formation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daflon (Diosmin and Hesperidin) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- interventionNames
- Drug: Daflon (Diosmin and Hesperidin)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Control group did not receive Daflon.
Primary outcomes (1)
- measure
- post-operative seroma formation
- timeFrame
- 8 weeks
- description
- reduction of post-operative seroma formation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDCalpin 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