Efficacy Study of Ifabond in Breast Cancer Surgery (Ifabond)
Primary Purpose
Breast Cancer, Lymphocele
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IFABOND (TM)
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility 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
Sites / Locations
- Hôpital Euroépen Marseille
- Centre de Chirurgie Gynecologique Et Des Maladies Du Sein
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm A: Applying Ifabond
Arm B: without Ifabond
Arm Description
The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients.
The synthetic adhesive solution Ifabond, will not be applied at the end of conventional breast cancer surgery in arm B patients.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01742975
First Posted
December 3, 2012
Last Updated
August 25, 2016
Sponsor
Michel Conte, M.D.
Collaborators
Peters surgical
1. Study Identification
Unique Protocol Identification Number
NCT01742975
Brief Title
Efficacy Study of Ifabond in Breast Cancer Surgery
Acronym
Ifabond
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michel Conte, M.D.
Collaborators
Peters surgical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
Arm A: Applying Ifabond
Arm B: Without Ifabond
Patients will be stratified according to these two criteria:
Axillary Lymph Node Dissection planned (ALND)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lymphocele
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Applying Ifabond
Arm Type
Experimental
Arm Description
The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients.
Arm Title
Arm B: without Ifabond
Arm Type
No Intervention
Arm Description
The synthetic adhesive solution Ifabond, will not be applied at the end of conventional breast cancer surgery in arm B patients.
Intervention Type
Device
Intervention Name(s)
IFABOND (TM)
Other Intervention Name(s)
An authorized device with CE labeling.
Intervention Description
The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients
Primary Outcome Measure Information:
Title
Change in seroma formation
Description
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.
Time Frame
Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery
Secondary Outcome Measure Information:
Title
Change in discomfort alleged by the patient
Description
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.
Time Frame
day 3 (or 7), day 15 and day 30
Other Pre-specified Outcome Measures:
Title
Change in the number of needle aspiration required
Description
The number of needle aspiration required at day 15 and day30 (-or- 2 days) post surgery will be documented.
Time Frame
day 15 and day 30
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel CONTE, MD
Organizational Affiliation
Hôpital Européen Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Euroépen Marseille
City
Marseille
State/Province
Paca
ZIP/Postal Code
13003
Country
France
Facility Name
Centre de Chirurgie Gynecologique Et Des Maladies Du Sein
City
Grenoble
State/Province
Rhône-Alpes
ZIP/Postal Code
38000
Country
France
12. IPD Sharing Statement
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Efficacy Study of Ifabond in Breast Cancer Surgery
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