- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01742975
Efficacy Study of Ifabond in Breast Cancer Surgery (Ifabond)
August 25, 2016 updated by: Michel Conte, M.D.
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
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.
Study Type
Interventional
Enrollment (Actual)
104
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Paca
-
Marseille, Paca, France, 13003
- Hôpital Euroépen Marseille
-
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Rhône-Alpes
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Grenoble, Rhône-Alpes, France, 38000
- Centre de Chirurgie Gynecologique Et Des Maladies Du Sein
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
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.
|
The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients
Other Names:
|
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
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.
|
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
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.
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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
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.
|
day 15 and day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michel CONTE, MD, Hôpital Européen Marseille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 (ESTIMATE)
December 6, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
August 26, 2016
Last Update Submitted That Met QC Criteria
August 25, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCB ID: 2011-A01014-37
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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