At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intraoperative Microbial Contamination, Its Prevention and Its Consequences for Outcomes Following Joint Replacement Surgery
In Brief
A clinical study evaluating Ioban for Periprosthetic Joint Infection. Completed, enrolled 1,661 participants across 3 sites.
Detailed Summary
This is a randomized, controlled study which aims to show whether iodine impregnated incisional foil (IobanTM) has a place in the prevention of prosthetic joint infection (PJI). 1200 patients will be included in this study and will be followed through out a ten year period. Follow up will center on the function of the prosthetic knee, early and late infection rates and revision surgery due to aseptic loosening. Our purpose is to gain insight in to the causes of post-operative infection in joint alloplasty surgery. Our hypothesis' are: 1. The patient's skin flora is the main source of intraoperative contamination, 2. Intraoperative contamination can be reduced by using IobanTM 3. Intraoperative contamination strongly predicts postoperative infection 4. Unsuccessful clinical outcomes of knee arthroplasty are caused by low-grade infections. To our knowledge this is the first study with this large a sample size and as long a follow up. Background PJI is a devastating complication with substantial morbidity and high socio economic costs. Revision surgery due to infection costs as much as six times more than the primary surgery and has a poorer outcome for the patient i.e. disability, pain or loss of function. Methods and materials The study has two main arms: 1. Intraoperative contamination 2. Postoperative infection The first stage aims to document that patients with intraoperative contamination have a larger risk of developing postoperative infection and include a study of the effect of Ioban™. The second stage are to include methods of PCR (polymerase chain reaction) and fluorescence microscopy, to demonstrate bacterial contamination and/or infection of any implants removed during the study period. Perspectives This study will give us new insight in the causes of PJI and the correlation with contamination during surgery. If IobanTM is proved to prevent infection it is a simple way to prevent post-operative infection and can be implemented in any orthopedic department.