Clinical trial · Interventional
Efficacy Study of Ifabond in Breast Cancer Surgery
A Randomized Study Evaluating the Efficacy of the Synthetic Adhesive Solution Ifabond, in Reducing Seroma Formation Post Surgery in Breast Cancer Patients, When Used in Partial Mastectomy With or Without Axillary Lymph Node Dissection
- 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)
A randomized prospective simple-blind interventional study evaluating the efficacy of the synthetic adhesive solution "Ifabond", in patients undergoing breast cancer surgery. The main objective of this study is to determine if the application of Ifabond, in addition to the conventional method of breast surgery, reduces the postoperative seroma formation. The secondary objective is to assess quality of life immediately after surgery, and the need for needle aspiration of the axilla, when using Ifabond.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lymphocele | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IFABOND (TM) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Applying Ifabond
- description
- The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients.
- interventionNames
- Device: IFABOND (TM)
- type
- NO_INTERVENTION
- label
- Arm B: without Ifabond
- description
- The synthetic adhesive solution Ifabond, will not be applied at the end of conventional breast cancer surgery in arm B patients.
Primary outcomes (1)
- measure
- Change in seroma formation
- timeFrame
- Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery
- description
- The volume of drain at Day 3 (or 7 in case of axillary lymph node dissection) post surgery will be documented, then patients will have an ultrasound exam at day 15 and day 30 (+or- 2 days) to measure seroma.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * "Eastern Cooperative Oncology Group" ECOG status ≤ 2 * Diagnosis of invasive or In situ breast cancer * Patient undergoing partial mastectomy with or without axillary lymph node dissection,(without communication between the two surgical loges) Exclusion Criteria: * Pregnant or breast-feeding patient * Participation at another protocol with an Investigational drug (within the last 4 weeks before enrollment) * Known hypersensitivity to Cyanoacrylate * Known hypersensitivity to formaldehyde * Patient who experience systemic infections preoperatively, or have conditions that are known to interfere with the healing process * Patient with uncontrolled diabetes
References
Publications (0)
Data not yet available