Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery

Orthopedic Disorder Clinical Trial

— ISO  

Official title:

Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03040960
• Other study ID #: 38RC16.223
• Secondary ID: 1985246
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2017
• Last updated: October 10, 2017
• Start date: August 2016
• Est. completion date: August 2018

Study information

• Verified date: October 2017
• Source: University Hospital, Grenoble
• Contact: Caroline Landelle, PH
• Phone: 0033476765643
• Email: clandelle[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Musculoskeletal Diseases
• Orthopedic Disorder
• Staphylococcus Aureus
• Surgical Wound Infection
• Traumatology
• Wound Infection

Locations

Country	Name	City	State
France	University Hospital, Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & 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. — View 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. Review. — View Citation

Lepelletier D, Saliou P, Lefebvre A, Lucet JC, Grandbastien B, Bruyère 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The incidence rate trend of S. aureus SSI over the year.	linear regression slope test of S. aureus SSI incidence rates by years	from january 1st 2012 to april 30th 2015