Efficacy Study of Ifabond in Breast Cancer Surgery

NCT01742975 | Completed

• 1 other identifier: 11-15 ONC HAP
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Lymphocele

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in discomfort alleged by the patient

  day 3 (or 7), day 15 and day 30

Other Outcomes (1)

• Change in the number of needle aspiration required

  day 15 and day 30

Study Arms (2)

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.

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.

Interventions

IFABOND (TM) DEVICE

The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients

Also known as: An authorized device with CE labeling.

Arm A: Applying Ifabond

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• "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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (2)

Centre de Chirurgie Gynecologique Et Des Maladies Du Sein

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Location

Hôpital Euroépen Marseille

Marseille, PACA, 13003, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphocele

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Cysts; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Michel CONTE, MD

  Hôpital Européen Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2012
• First Posted: December 6, 2012
• Study Start: November 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: February 1, 2016
• Last Updated: September 25, 2025

Record last verified: 2016-08

Locations

FR (2)