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Efficacy Study of Ifabond in Breast Cancer Surgery

Sponsor
Michel Conte, M.D. (Other)
Overall Status
Completed
CT.gov ID
NCT01742975
Collaborator
Peters surgical (Other)
104
Enrollment
2
Locations
2
Arms
51
Duration (Months)
52
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: IFABOND (TM)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
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 Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Applying Ifabond

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

Device: IFABOND (TM)
The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients
Other Names:
  • An authorized device with CE labeling.

    		•
    No Intervention: Arm B: without Ifabond

    The synthetic adhesive solution Ifabond, will not be applied at the end of conventional breast cancer surgery in arm B patients.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Other Outcome Measures

    1. Change in the number of needle aspiration required [day 15 and day 30]

      The number of needle aspiration required at day 15 and day30 (-or- 2 days) post surgery will be documented.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Euroépen Marseille Marseille Paca France 13003
    2 Centre de Chirurgie Gynecologique Et Des Maladies Du Sein Grenoble Rhône-Alpes France 38000

    Sponsors and Collaborators

    • Michel Conte, M.D.
    • Peters surgical

    Investigators

    • Principal Investigator: Michel CONTE, MD, Hôpital Européen Marseille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michel Conte, M.D., Michel CONTE, obstetrician gynecologist surgeon, Hôpital Européen Marseille
    ClinicalTrials.gov Identifier:
    NCT01742975
    Other Study ID Numbers:
    • RCB ID: 2011-A01014-37
    First Posted:
    Dec 6, 2012
    Last Update Posted:
    Aug 26, 2016
    Last Verified:
    Aug 1, 2016
    Additional relevant MeSH terms:
    Breast Neoplasms
    Lymphocele

    Study Results

    No Results Posted as of Aug 26, 2016