Efficacy Study of Ifabond in Breast Cancer Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Hôpital Européen Marseille
Sponsor:
Collaborator:
IfaMEDICAL
Information provided by (Responsible Party):
Michel Conte, M.D., Hôpital Ambroise Paré
ClinicalTrials.gov Identifier:
NCT01742975
First received: December 3, 2012
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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
Lymphocele
Device: IFABOND (TM)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The number of needle aspiration required at day 15 and day30 (-or- 2 days) post surgery will be documented.


Estimated Enrollment: 102
Study Start Date: November 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742975

Contacts
Contact: Wahiba BIDAUT, senior CRA (33)4-91-83-38-38 ext 3155 w_bidaut@ch-ambroisepare.fr
Contact: Penda SOW, CRA (33)4-91-83-38-38 ext 3105 mp_sow@ch-ambroisepare.fr

Locations
France
Hôpital Ambroise Paré Recruiting
Marseille, Paca, France, 13006
Contact: Wahiba BIDAUT, senior CRA    (33)4-91-83-38-38 ext 3155    w_bidaut@ch-ambroisepare.fr   
Contact: Penda SOW, CRA    (33)4-91-83-38-38 ext 3105    mp_sow@ch-ambroisepare.fr   
Principal Investigator: Michel CONTE, MD         
Sub-Investigator: Bernard BLANC, MD/prof         
Sub-Investigator: Didier MATHIEU, MD/prof         
Sub-Investigator: Jean QUILICHINI, MD         
Centre de Chirurgie Gynecologique Et Des Maladies Du Sein Not yet recruiting
Grenoble, Rhône-Alpes, France, 38000
Contact: Raoul PAYAN, MD    04-76-42-98-01    raoul.payan@hotmail.fr   
Principal Investigator: Raoul PAYAN, MD         
Sponsors and Collaborators
Hôpital Européen Marseille
IfaMEDICAL
Investigators
Principal Investigator: Michel CONTE, MD Hôpital Ambroise Paré, Marseille
  More Information

No publications provided

Responsible Party: Michel Conte, M.D., Michel CONTE, obstetrician gynecologist surgeon, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier: NCT01742975     History of Changes
Other Study ID Numbers: RCB ID: 2011-A01014-37
Study First Received: December 3, 2012
Last Updated: December 5, 2012
Health Authority: France: ANSM (Agence nationale de sécurité du médicament et des produits de santé)

Additional relevant MeSH terms:
Breast Neoplasms
Lymphocele
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cysts
Lymphatic Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014