NCT03040960

Brief Summary

The most commonly identified organism for Surgical Site Infection (SSI) in orthopedic surgery is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known. The aim of this study was to evaluated the incidence rate of S. aureus SSI over the years and risk factors of these infections in a french University Hospital.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

January 31, 2017

Last Update Submit

October 10, 2017

Conditions

Staphylococcus AureusSurgical Wound InfectionOrthopedic DisorderTraumatology

Keywords

infectionwound infectionsurgical wound infectionStaphylococcal infectionswound and injuriespostoperative complicationsGram-positive bacterial infectionsbacterial infections

Outcome Measures

Primary Outcomes (1)

  • Risk factors of S. aureus surgical site infections.

    univariate analysis of potential risk factors. Data with p value less than 0.1 were included in a logistic regression model

    up to 1 year following surgery

Secondary Outcomes (1)

  • The incidence rate trend of S. aureus SSI over the year.

    from january 1st 2012 to april 30th 2015

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing orthopedic or traumatologiy surgeries in Grenoble university hospital

You may qualify if:

  • orthopedic or traumatology surgeries performed in Grenoble University Hospital,
  • from january 1st 2012 to april 30th 2015,
  • the subject is undergoing one of the following surgical procedures : knee and hip arthroplasties, osteosynthesis of proximal femur and other osteosynthesis except skull and spine.
  • the subject is 16 years of age or older

You may not qualify if:

  • non orthopedic or trauma surgery performed in Grenoble University Hospital,
  • spine surgeries,
  • surgeries of the hand, scaphoid and carpal bones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Grenoble Alpes

Grenoble, 38043, France

RECRUITING

Related Publications (5)

  • Kalmeijer MD, van Nieuwland-Bollen E, Bogaers-Hofman D, de Baere GA. Nasal carriage of Staphylococcus aureus is a major risk factor for surgical-site infections in orthopedic surgery. Infect Control Hosp Epidemiol. 2000 May;21(5):319-23. doi: 10.1086/501763.

    PMID: 10823564BACKGROUND

  • Korol E, Johnston K, Waser N, Sifakis F, Jafri HS, Lo M, Kyaw MH. A systematic review of risk factors associated with surgical site infections among surgical patients. PLoS One. 2013 Dec 18;8(12):e83743. doi: 10.1371/journal.pone.0083743. eCollection 2013.

    PMID: 24367612BACKGROUND

  • Marimuthu K, Eisenring MC, Harbarth S, Troillet N. Epidemiology of Staphylococcus aureus Surgical Site Infections. Surg Infect (Larchmt). 2016 Apr;17(2):229-35. doi: 10.1089/sur.2015.055. Epub 2015 Dec 31.

    PMID: 26720215BACKGROUND

  • Lepelletier D, Saliou P, Lefebvre A, Lucet JC, Grandbastien B, Bruyere F, Stahl JP, Keita-Perse O, Berthelot P, Aho S; workgroup SF2H. "Preoperative risk management: strategy for Staphylococcus aureus preoperative decolonization" (2013 update). French society of Hospital Hygiene. Med Mal Infect. 2014 Jun;44(6):261-7. doi: 10.1016/j.medmal.2014.04.003. Epub 2014 May 14. No abstract available.

    PMID: 24835378BACKGROUND

  • Webster J, Osborne S. Preoperative bathing or showering with skin antiseptics to prevent surgical site infection. Cochrane Database Syst Rev. 2015 Feb 20;2015(2):CD004985. doi: 10.1002/14651858.CD004985.pub5.

    PMID: 25927093BACKGROUND

MeSH Terms

Conditions

Staphylococcal InfectionsSurgical Wound InfectionMusculoskeletal DiseasesInfectionsWound InfectionWounds and InjuriesPostoperative ComplicationsGram-Positive Bacterial InfectionsBacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Caroline landelle, PH

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Landelle, PH

CONTACT

0033476765643clandelle@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 2, 2017

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)