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

Total Hip Replacement Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02272205
• Other study ID #: 004-14
• Status: Not yet recruiting
• Phase: N/A
• First received: October 20, 2014
• Last updated: October 20, 2014
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2014
• Source: University Hospital, Strasbourg, France
• Contact: Jean-Yves JENNY, MD
• Phone: 33.3.88.55.21.45
• Email: jean-yves.jenny[@]chru-strasbourg.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Other:
• Retrospective analysis of records

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concordance of pre-and intraoperative bacteriological documentation	concordance of pre-and intraoperative bacteriological documentation (division into 3 classes: complete, partial, no - Chi-square test	preoperative; intraoperative	No
Secondary	rates to relapse of the initial infection or a new infection	rates to relapse of the initial infection or a new infection (survival curves according to Kaplan-Meier with log-rank test)	preoperative; intraoperative	No