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Intraoperative Microbial Contamination (ICON)

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ClinicalTrials.gov Identifier: NCT03139539
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
Frederiksberg University Hospital
Hillerod Hospital, Denmark
Aarhus University Hospital
Information provided by (Responsible Party):
Anne Brun Hesselvig, University of Copenhagen

Brief 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.


Condition or disease Intervention/treatment Phase
Periprosthetic Joint Infection Device: Ioban Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1661 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intraoperative Microbial Contamination, Its Prevention and Its Consequences for Outcomes Following Joint Replacement Surgery
Study Start Date : March 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : October 2018

Arm Intervention/treatment
Active Comparator: Ioban
In this arm patients will be operated using Ioban as incisional drape.
Device: Ioban
Other Name: iodine impregnated incisional foil

No Intervention: Control
In this arm patients will be operated using no incisional drape.



Primary Outcome Measures :
  1. Does Ioban prevent intraoperative microbial contamination? [ Time Frame: approximately 2 hours. Sampling is done during surgery. ]
    A randomized controlled study is performed to determine the effect of iodine impregnated incisional drape on intraoperative contamination. The primary outcome is the frequency of intraoperative contamination in the projects' two arms.

  2. Sources of intraoperative contamination [ Time Frame: approximately 2 hours. Sampling is done during surgery. ]

    A prospective study is performed to assess the frequency of intraoperative contamination. During standard knee arthroplasty surgeries the samples are obtained.

    Three swabs, (Copan ESwab) will be taken during surgery. The first swab is taken from the skin of the surgical site prior to skin preparation. The second swab just after incision and will be of the wound edges.

    Intra-operative contaminants are cultured from the glove of the surgeon's dominant hand using a special glove culture technique with samples taken 30 minutes after skin incision (or before changing gloves when handling implants or using bone cement impregnated with antibiotics - whichever comes first) and the third swab is taken from the skin edges after closure of the subcutaneous tissue before closure of the skin. All the samples will be cultured and undergo susceptability testing.

    Analysis will determine the most frequent source of contamination.



Secondary Outcome Measures :
  1. Postoperative infections are caused (are not caused) by intra-operative contamination. [ Time Frame: Approximately 4 hours. Sampling done during revision surgery ]

    The bacteriology of postoperative, clinical infections will be compared to the intra-operative contamination.

    Kamme-Lindberg biopsies will be taken from these cases (debridements or revisions) as per usual clinical procedures. Extensive biofilm analyses will be performed of explants and biopsies and compared to extensive analyses of the glove samples from the primary procedure.

    Kamme-Lindberg biopsies will be taken from these cases (debridements or revisions) as per usual clinical procedures. Extensive biofilm analyses will be performed of explants and biopsies and compared to extensive analyses of the glove samples from the primary procedure.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients of 18 years of age or older scheduled for primary knee arthroplasty surgery will be eligible for inclusion in the study

Exclusion Criteria:

  • known allergy or hypersensitivity to iodine or adhesive drape
  • history of infection in the knee (e.g. septic arthritis, osteomyelitis)
  • active infection at another site at the time of surgery
  • antibiotic use within 4 weeks before surgery
  • previous enrolment in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139539


Locations
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Denmark
Aarhus Universitetshospital
Aarhus, Denmark, 8000
Herlev and Gentofte Hospital
Gentofte, Denmark, 2900
Nordsjællands Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
University of Copenhagen
Frederiksberg University Hospital
Hillerod Hospital, Denmark
Aarhus University Hospital
Investigators
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Principal Investigator: Thomas Bjarnsholt University of Copenhagen

Additional Information:
Publications:

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Responsible Party: Anne Brun Hesselvig, MD, Primary Investigator, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03139539     History of Changes
Other Study ID Numbers: H-15012754
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We are making a database and keeping the records for ten years. Fellow researchers will have acces to the database.