Sonication of Explanted Breast Implants for Detection of Subclinical Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01138891

Enrollment

121

Registered

2010-06-08

Start date

2006-02-28

Completion date

2010-06-30

Last updated

2010-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implants, Breast

Keywords

Breast implants, capsular contraction, sonication, biofilm, Complications, surgery

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 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Outcome results