An interventional study of IFABOND (TM) in Breast Cancer and Lymphocele, sponsored by Hôpital Européen Marseille. Completed at 2 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Hôpital Européen Marseille · Not applicable, Interventional, and Supportive care
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.
Breast cancer patients will be selected at their preoperative visit with the surgeon, who will inform them about the study and answer their questions.
Patients who consent to participate will be randomized to one of two arms:
Patients will be stratified according to these two criteria:
The following parameters will be measured:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 104 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hôpital Européen Marseille is the lead sponsor of 30 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients.
Device: IFABOND (TM)
The synthetic adhesive solution Ifabond, will not be applied at the end of conventional breast cancer surgery in arm B patients.
The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients
Also known as: An authorized device with CE labeling.
Change in seroma formation
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.
Time frame: Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery
Change in discomfort alleged by the patient
Patients will be asked if they feel any discomfort in relation to seroma formation at Day 3 (or 7 in case of axillary lymph node dissection),day15 and day 30 (-or- 2 days) post surgery.
Time frame: day 3 (or 7), day 15 and day 30
Change in the number of needle aspiration required
The number of needle aspiration required at day 15 and day30 (-or- 2 days) post surgery will be documented.
Time frame: day 15 and day 30
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Hôpital Européen Marseille