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