Efficacy Study of Ifabond in Breast Cancer Surgery (NCT01742975) | Clinical Trial Compass
CompletedNot Applicable
Efficacy Study of Ifabond in Breast Cancer Surgery
France104 participantsStarted 2011-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in seroma formation
Timeframe: Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery