Efficacy Study of Ifabond in Breast Cancer Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Arm A: Applying Ifabond Arm B: Without Ifabond Patients will be stratified according to these two criteria: Axillary Lymph Node Dissection planned (ALND) Body Mass Index (BMI) The following parameters will be measured: ECOG status and Blood Pressure at day 3(day 7 in case of ALND), day 15 and day 30 post surgery Volume of drainage at day 3 and at (day 7 in case of ALND)post surgery Discomfort alleged by the patient at day 3(day 7 in case of ALND), day 15 and day 30 post surgery Lymphocele volume measured by ultrasound at day 15 and day 30 post surgery If the volume is ≥ 100cc, a needle aspiration will be performed, and the volume of aspirate will be documented. Adverse events and concomitant medications will be collected throughout the study until 30 days after the last ultrasound.

Official Title
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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

Conditions
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Breast Cancer, Lymphocele

Intervention / Treatment
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* Device: IFABOND (TM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Applying Ifabond<br>The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients. | Device: IFABOND (TM)<br>* The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients<br>* Other names: An authorized device with CE labeling.;|
| No Intervention: Arm B: without Ifabond<br>The synthetic adhesive solution Ifabond, will not be applied at the end of conventional breast cancer surgery in arm B patients. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |