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

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02272205
• Collaborator: (none)
• Enrollment: 80
• Duration (Months): 11

Study Details

Study Description

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	Phase
Total Hip Replacement	Other: Retrospective analysis of records

Study Design

• Study Type: Observational
• Anticipated 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: Nov 1, 2014
• Anticipated Primary Completion Date: Oct 1, 2015
• Anticipated Study Completion Date: Oct 1, 2015

Outcome Measures

Primary Outcome Measures

1. concordance of pre-and intraoperative bacteriological documentation [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 [preoperative; intraoperative]

   rates to relapse of the initial infection or a new infection (survival curves according to Kaplan-Meier with log-rank test)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT02272205
• Other Study ID Numbers: 004-14
• First Posted: Oct 22, 2014
• Last Update Posted: Oct 22, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by University Hospital, Strasbourg, France: Hip replacement; Knee replacement; Knee infection; Hip infection; Antibiotic prophylaxis

Study Results

No Results Posted as of Oct 22, 2014