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Efficacy Study of Ifabond in Breast Cancer Surgery (Ifabond)

This study has been completed.
Peters surgical
Information provided by (Responsible Party):
Michel Conte, M.D., Hôpital Européen Marseille Identifier:
First received: December 3, 2012
Last updated: August 25, 2016
Last verified: August 2016
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.

Condition Intervention
Breast Cancer
Device: IFABOND (TM)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hôpital Européen Marseille:

Primary Outcome Measures:
  • Change in seroma formation [ Time Frame: Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery ]
    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.

Secondary Outcome Measures:
  • Change in discomfort alleged by the patient [ Time Frame: day 3 (or 7), day 15 and day 30 ]
    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.

Other Outcome Measures:
  • Change in the number of needle aspiration required [ Time Frame: day 15 and day 30 ]
    The number of needle aspiration required at day 15 and day30 (-or- 2 days) post surgery will be documented.

Enrollment: 104
Study Start Date: November 2011
Study Completion Date: February 2016
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01742975

Hôpital Euroépen Marseille
Marseille, Paca, France, 13003
Centre de Chirurgie Gynecologique Et Des Maladies Du Sein
Grenoble, Rhône-Alpes, France, 38000
Sponsors and Collaborators
Michel Conte, M.D.
Peters surgical
Principal Investigator: Michel CONTE, MD Hôpital Européen Marseille
  More Information

Responsible Party: Michel Conte, M.D., Michel CONTE, obstetrician gynecologist surgeon, Hôpital Européen Marseille Identifier: NCT01742975     History of Changes
Other Study ID Numbers: RCB ID: 2011-A01014-37
Study First Received: December 3, 2012
Last Updated: August 25, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Lymphatic Diseases
Pharmaceutical Solutions processed this record on April 27, 2017