Efficacy Study of Ifabond in Breast Cancer Surgery

Not Applicable

Completed

• Conditions: Lymphocele; Breast Cancer
• Interventions: Device: IFABOND (TM)

• Registration Number: NCT01742975
• Lead Sponsor: Michel Conte, M.D.

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-06
• Primary Completion: 2015-04
• Study Completion: 2016-02
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Applying Ifabond	IFABOND (TM)	The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients.

Primary Outcome Measures

Name	Time	Method
Change in seroma formation	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.

Secondary Outcome Measures

Name	Time	Method
Change in discomfort alleged by the patient	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.

Trial Locations

Locations (2)

Centre de Chirurgie Gynecologique Et Des Maladies Du Sein; 🇫🇷 Grenoble, Rhône-Alpes, France

Hôpital Euroépen Marseille; 🇫🇷 Marseille, Paca, France