Clinical trial NCT03040960: Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery
Official title: Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Staphylococcus Aureus
Surgical Wound Infection
Orthopedic Disorder
Traumatology
Keywords: infection
wound infection
surgical wound infection
Staphylococcal infections
wound and injuries
postoperative complications
Gram-positive bacterial infections
bacterial infections
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing orthopedic or traumatologiy surgeries in Grenoble university hospital

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.

Detailed description: Surgical site infections (SSI) in orthopedic surgery are responsible for reduced quality of life, increased length of hospital stay and costs. The most commonly identified organism is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known.The aim of this study was to evaluate the incidence rate trend of S. aureus SSI over the years and risk factors of theses infections in a french University Hospital.

The knowledge obtained by this study will enable identification of the surgical patients most at risk of developping S. aureus SSI, and who would probably benefit most from new interventions given prophylactically and specifically to prevent S. aureus infections.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Risk factors of S. aureus surgical site infections.
timeFrame: up to 1 year following surgery
Secondary outcomes:
measure: The incidence rate trend of S. aureus SSI over the year.
timeFrame: from january 1st 2012 to april 30th 2015
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital, Grenoble Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Caroline landelle, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.