NCT01742975

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Hôpital Européen Marseille · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Breast Cancer
• Lymphocele

Interventions

Type	Name	Description
DEVICE	IFABOND (TM)	The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-04-01
• Completion: 2016-02-01
• First posted: 2012-12-06
• Last updated: 2025-09-25

Locations

2 sites across 1 country: France