Clinical Trial: Sonication of Explanted Breast Implants for Detection of Subclinical Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title:

Brief Summary:

Objective. Capsular contracture is a frequent complication after breast implantation with unclear etiology.

Summary Background Data: Microorganisms may trigger chronic periimplant inflammation with subsequent capsular fibrosis.

Study Hypothesis: The investigators hypothesize that with sonication adherent microorganisms can be detected on removed implants .

Methods: In a prospective multicentre study all breast implants explanted are collected to be analyzed by sonication. The resulting culture results are correlated with patient, surgical and implant characteristics.

Detailed Summary: The study is performed in order to find a correlation between the degree of capsular fibrosis and presence of biofilm bacteria on the surface of the implant.
Sponsor: Centre Hospitalier Universitaire Vaudois

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Centre Hospitalier Universitaire Vaudois

Dates:
Date Received: June 7, 2010
Date Started: February 2006
Date Completion:
Last Updated: June 8, 2010
Last Verified: June 2010