Staphylococcus AureusISONCT03040960
Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery
An observational study of Staphylococcus Aureus and Surgical Wound Infection, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Staphylococcus Aureus, Surgical Wound Infection, Orthopedic Disorder
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2016to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing orthopedic or traumatologiy surgeries in Grenoble university hospital
Who may be able to join
- 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
Who cannot join
- non orthopedic or trauma surgery performed in Grenoble University Hospital,
- spine surgeries,
- surgeries of the hand, scaphoid and carpal bones.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital, Grenoble Alpes
Grenoble, 38043
Caroline Landelle, 0033476765643, clandelle@chu-grenoble.fr
About this study
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.
Read the 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.
- Keywords
- infection, wound infection, surgical wound infection, Staphylococcal infections, wound and injuries, postoperative complications, Gram-positive bacterial infections, bacterial infections
- Medical subject headings
- Staphylococcal Infections, Surgical Wound Infection, Musculoskeletal Diseases, Infections, Wound Infection, Wounds and Injuries, Postoperative Complications, Gram-Positive Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 1 year following surgery
Secondary outcomes (1)
The incidence rate trend of S. aureus SSI over the year.
linear regression slope test of S. aureus SSI incidence rates by years
Measured: from january 1st 2012 to april 30th 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline landelle, PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040960
- Sponsor's protocol ID
- 38RC16.223
- Other IDs
- 1985246
- Acronym
- ISO
- Status last verified
- Oct 2017
- First submitted
- 31 Jan 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. doi: 10.1086/501763.
PubMed 10823564Korol 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.
PubMed 24367612Marimuthu 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.
PubMed 26720215Lepelletier 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.
PubMed 24835378Webster 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.
PubMed 25927093
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery
- ClinicalTrials.gov ID
- NCT03040960
- Acronym / sponsor ID
- ISO / 38RC16.223
- Keywords
- infection, wound infection, surgical wound infection, Staphylococcal infections, wound and injuries, postoperative complications, Gram-positive bacterial infections, bacterial infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing orthopedic or traumatologiy surgeries in Grenoble university hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- non orthopedic or trauma surgery performed in Grenoble University Hospital,
- spine surgeries,
- surgeries of the hand, scaphoid and carpal bones.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
The incidence rate trend of S. aureus SSI over the year.
Time frame: from january 1st 2012 to april 30th 2015
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Background: PubMed 10823564Kalmeijer 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.
- Background: PubMed 24367612Korol 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.
- Background: PubMed 26720215Marimuthu 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.
- Background: PubMed 24835378Lepelletier 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.
- Background: PubMed 25927093Webster 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.
- Individual participant dataSharing planned: No
Related trials for Staphylococcus Aureus
RecruitingObservational study
Study of the Nasal Intracellular Reservoir of Staphylococcus Aureus in Patients With S. Aureus Bacteremia
Bacteria Infection Mechanism
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline landelle, PH principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus and Surgical Wound Infection, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Landelle, PH (0033476765643, clandelle@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors of S. aureus surgical site infections. (time frame: up to 1 year following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03040960, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.