Clinical Trial: Efficacy Study of Ifabond in Breast Cancer Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 With

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 Summary:

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.

Sponsor: Michel Conte, M.D.

Current Primary Outcome: Change in seroma formation [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in discomfort alleged by the patient [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Hôpital Européen Marseille

Dates:
Date Received: December 3, 2012
Date Started: November 2011
Date Completion:
Last Updated: August 25, 2016
Last Verified: August 2016