CompletedNot Applicable

Efficacy Study of Ifabond in Breast Cancer Surgery

France104 participantsStarted 2011-11

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in seroma formation

Timeframe: Day 3 (or 7 in case of axillary lymph node dissection), day15 and day 30 post surgery

Trial details

NCT IDNCT01742975

SponsorHôpital Européen Marseille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04

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