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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Applying Ifabond | Experimental | The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients. |
|
| Arm B: without Ifabond | No Intervention | The synthetic adhesive solution Ifabond, will not be applied at the end of conventional breast cancer surgery in arm B patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IFABOND (TM) | Device | The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 3 (or 7), day 15 and day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 15 and day 30 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michel CONTE, MD | Hôpital Européen Marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Chirurgie Gynecologique Et Des Maladies Du Sein | Grenoble | Auvergne-Rhône-Alpes | 38000 | France | ||
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008210 | Lymphocele |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Hôpital Euroépen Marseille |
| Marseille |
| PACA |
| 13003 |
| France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003560 | Cysts |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |