Sonication of Explanted Breast Implants for Detection of Subclinical Infection

Vaud University Hospital Center

Status: Completed

Conditions: Implants, Breast

Study type: Observational

Funder types: Other

Identifiers

NCT01138891

EKBB_2008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 121 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years or more
• Undergoing breast implant removal for any reason at one of the participating center
• Explantation of breast implant performed between February 2006 and March 2009

Exclusion criteria

• Obvious contamination of the breast implant in the operating room or during transportation.

Trial design

121 participants in 1 patient group

Removed breast implants for any reason