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

• ClinicalTrials.gov Identifier: NCT03040960
• Recruitment Status: Unknown
• First Posted: February 2, 2017
• Last Update Posted: October 11, 2017
• Sponsor: University Hospital, Grenoble
• Information provided by (Responsible Party): University Hospital, Grenoble

Study Description

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.

Condition or disease
Staphylococcus Aureus; Surgical Wound Infection; Orthopedic Disorder; Traumatology

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 150 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery
• Study Start Date: August 2016
• Estimated Primary Completion Date: August 2018
• Estimated Study Completion Date: August 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Risk factors of S. aureus surgical site infections. [ Time Frame: up to 1 year following surgery ]
   univariate analysis of potential risk factors. Data with p value less than 0.1 were included in a logistic regression model

Secondary Outcome Measures :

1. The incidence rate trend of S. aureus SSI over the year. [ Time Frame: from january 1st 2012 to april 30th 2015 ]
   linear regression slope test of S. aureus SSI incidence rates by years

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing orthopedic or traumatologiy surgeries in Grenoble university hospital

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.

Contacts and Locations

Contacts

Contact: Caroline Landelle, PH; 0033476765643; clandelle@chu-grenoble.fr

Locations

France

University Hospital, Grenoble Alpes; Recruiting

Grenoble, France, 38043

Contact: Caroline Landelle 0033476765643 clandelle@chu-grenoble.fr

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

• Principal Investigator: Caroline landelle, PH; University Hospital, Grenoble

More Information

Publications:

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.

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.

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.

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.

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.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT03040960
• Other Study ID Numbers: 38RC16.223; 1985246 ( Other Identifier: CNIL )
• First Posted: February 2, 2017
• Last Update Posted: October 11, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:

infection; wound infection; surgical wound infection; Staphylococcal infections; wound and injuries; postoperative complications; Gram-positive bacterial infections; bacterial infections

Additional relevant MeSH terms:

Infection; Communicable Diseases; Surgical Wound Infection; Wound Infection; Musculoskeletal Diseases; Surgical Wound; Postoperative Complications; Pathologic Processes; Wounds and Injuries