Efficacy Study of Ifabond in Breast Cancer Surgery

Breast Cancer Clinical Trial

— Ifabond  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742975
• Other study ID #: RCB ID: 2011-A01014-37
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: August 25, 2016
• Start date: November 2011
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: ANSM (Agence nationale de sécurité du médicament et des produits de santé)
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphocele

Intervention

Device:
• IFABOND (TM)
The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients

Locations

Country	Name	City	State
France	Centre de Chirurgie Gynecologique Et Des Maladies Du Sein	Grenoble	Rhône-Alpes
France	Hôpital Euroépen Marseille	Marseille	Paca

Sponsors (2)

Lead Sponsor	Collaborator
Michel Conte, M.D.	Peters surgical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the number of needle aspiration required	The number of needle aspiration required at day 15 and day30 (-or- 2 days) post surgery will be documented.	day 15 and day 30	No
Primary	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.	Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery	No
Secondary	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.	day 3 (or 7), day 15 and day 30	No