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Intraoperative Microbial Contamination

NCT03139539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1661

Last updated 2018-10-15

No results posted yet for this study

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.

Conditions

  • Periprosthetic Joint Infection

Interventions

DEVICE

Ioban

Sponsors & Collaborators

  • Frederiksberg University Hospital

    collaborator OTHER

  • Hillerod Hospital, Denmark

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Thomas Bjarnsholt · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-04-30
Completion
2018-10-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03139539 on ClinicalTrials.gov