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Evaluation of Conventional Antibiotic Prophylaxis During a Change of Hip or Knee Infected at a Time

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ClinicalTrials.gov Identifier: NCT02272205
Recruitment Status : Unknown
Verified October 2014 by University Hospital, Strasbourg, France.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

Infection is a serious complications after undergoing total hip replacement. It occurs in about 1% of cases. The optimal treatment of these infections is discussed. The team validated by international publications change strategy of the infected prosthesis at a time.

Antibiotic prophylaxis has significantly reduced the infection intraoperative contamination in orthopedic surgery rates. It must be conventionally administered before the surgical incision. In response to infection, it is typically recommended to start this antibiotic after the completion of the deep bacteriological samples, so as not to negate the risk of these samples by the prior administration of antibiotics. This attitude, however, is not formally validated by the scientific literature. In contrast, two recent publications challenge this practice, and suggest the use of a conventional antibiotic prophylaxis even in septic interventions. Our multidisciplinary team opted for a few months for this new strategy. We wish to evaluate the influence of this new approach results in the treatment of infection in total hip or knee.


Condition or disease Intervention/treatment
Total Hip Replacement Other: Retrospective analysis of records

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Effect of a Conventional Antibiotic Prophylaxis on the Positivity of Intraoperative Bacteriological Samples During a Change of Hip or Knee Infected at a Time
Study Start Date : November 2014
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics




Primary Outcome Measures :
  1. concordance of pre-and intraoperative bacteriological documentation [ Time Frame: preoperative; intraoperative ]
    concordance of pre-and intraoperative bacteriological documentation (division into 3 classes: complete, partial, no - Chi-square test


Secondary Outcome Measures :
  1. rates to relapse of the initial infection or a new infection [ Time Frame: preoperative; intraoperative ]
    rates to relapse of the initial infection or a new infection (survival curves according to Kaplan-Meier with log-rank test)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
80 patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.
Criteria

Inclusion Criteria:

  • patients operated in service between January 2012 and July 2013 for treatment of an infection of total hip or knee.

Exclusion Criteria:

  • patients operated in service before January 2012 and after July 2013 for treatment of an infection of total hip or knee.

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): NCT02272205


Contacts
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Contact: Jean-Yves JENNY, MD 33.3.88.55.21.45 jean-yves.jenny@chru-strasbourg.fr

Sponsors and Collaborators
University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02272205    
Other Study ID Numbers: 004-14
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014
Keywords provided by University Hospital, Strasbourg, France:
Hip replacement
Knee replacement
Knee infection
Hip infection
Antibiotic prophylaxis
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents