Efficacy Study of Ifabond in Breast Cancer Surgery

Hôpital Européen Marseille

Status: Completed

Conditions: Breast Cancer; Lymphocele

Treatments: Device: IFABOND (TM)

Study type: Interventional

Funder types: Other

Identifiers

NCT01742975

11-15 ONC HAP

Details and patient eligibility

About

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.

Full description

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:

1. Arm A: Applying Ifabond
2. Arm B: Without Ifabond

Patients will be stratified according to these two criteria:

1. Axillary Lymph Node Dissection planned (ALND)
2. 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.

Enrollment: 104 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Arm A: Applying Ifabond

Experimental group

Description:

The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients.

Treatment:

Device: IFABOND (TM)

Arm B: without Ifabond

No Intervention group

Description:

The synthetic adhesive solution Ifabond, will not be applied at the end of conventional breast cancer surgery in arm B patients.