Clinical trial NCT01742975: Efficacy Study of Ifabond in Breast Cancer Surgery
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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lymphocele
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
Collaborators: name: Peters surgical
First posted: 2012-12-06
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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 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

Primary outcomes:
measure: Change in seroma formation
timeFrame: Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery
Secondary outcomes:
measure: Change in discomfort alleged by the patient
timeFrame: day 3 (or 7), day 15 and day 30
Other outcomes:
measure: Change in the number of needle aspiration required
timeFrame: day 15 and day 30
Locations:
city: Marseille
country: France
facility: Hôpital Euroépen Marseille
state: Paca
city: Grenoble
country: France
facility: Centre de Chirurgie Gynecologique Et Des Maladies Du Sein
state: Rhône-Alpes
Study officials:
affiliation: Hôpital Européen Marseille
name: Michel CONTE, MD
role: PRINCIPAL_INVESTIGATOR
References: