Efficacy Study of Ifabond in Breast Cancer Surgery (Ifabond)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lymphocele
• Intervention / Treatment: Device: IFABOND (TM)

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • PACA
    • Marseille, PACA, France, 13003
      • Hôpital Euroépen Marseille
  • Rhône-Alpes
    • Grenoble, Rhône-Alpes, France, 38000
      • Centre de Chirurgie Gynecologique Et Des Maladies Du Sein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Applying Ifabond; 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 be applied at the end of conventional breast cancer surgery for arm A patients; Other Names: An authorized device with CE labeling.
No Intervention: Arm B: without Ifabond; 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?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hôpital Européen Marseille
• Collaborators: Peters surgical
• Investigators: Principal Investigator: Michel CONTE, MD, Hôpital Européen Marseille

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimated): December 6, 2012

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Lymphatic Diseases; Cysts; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Breast Neoplasms; Lymphocele
• Other Study ID Numbers: 11-15 ONC HAP