Breast CancerIfabondNCT01742975
Efficacy Study of Ifabond in Breast Cancer Surgery
A study testing IFABOND (TM) in people with Breast Cancer and Lymphocele, run by Hôpital Européen Marseille at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Lymphocele
- What is being tested?
- IFABOND (TM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2011to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- "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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de Chirurgie Gynecologique Et Des Maladies Du Sein
Grenoble, Auvergne-Rhône-Alpes, 38000
Hôpital Euroépen Marseille
Marseille, PACA, 13003
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Lymphocele
- Being tested
- IFABOND (TM)
- Medical subject headings
- Breast Neoplasms, Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFABOND (TM)Device
Also called An authorized device with CE labeling.
The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Applying Ifabond | Experimental | The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients. Receives: Device: IFABOND (TM) |
| Arm B: without Ifabond | No intervention | The synthetic adhesive solution Ifabond, will not be applied at the end of conventional breast cancer surgery in arm B patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery
Secondary outcomes (1)
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.
Measured: day 3 (or 7), day 15 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startNov 2011
- Primary completionApr 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel CONTE, MD, Principal investigator, Hôpital Européen Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742975
- Sponsor's protocol ID
- 11-15 ONC HAP
- Acronym
- Ifabond
- Status last verified
- Aug 2016
- First submitted
- 3 Dec 2012
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01742975
- Acronym / sponsor ID
- Ifabond / 11-15 ONC HAP
- Conditions
- Breast Cancer, Lymphocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Applying Ifabond | Experimental | Device: IFABOND (TM)The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients. |
| Arm B: without Ifabond | No intervention | –The synthetic adhesive solution Ifabond, will not be applied at the end of conventional breast cancer surgery in arm B patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- "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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFABOND (TM)Also: An authorized device with CE labeling.The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients | Device | Arm A: Applying Ifabond |
Primary outcome
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.
1 secondary outcome
Change in discomfort alleged by the patient
Time frame: day 3 (or 7), day 15 and day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel CONTE, MD principal investigator
Hôpital Européen Marseille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IFABOND (TM) in people with Breast Cancer and Lymphocele, run by Hôpital Européen Marseille at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in seroma formation (time frame: Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.