Surgical Site InfectionPRISCCANCT02392936
Evaluation of Peri-operative Risk Factors for Surgery Site Infection in Cardiac Surgery
An observational study of Surgical Site Infection, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
There is a recent increase in incidence of surgical site infection after cardiac surgery in our hospital, in spite of specific measures taken concerning some aspects of the surgical procedures, targeting a better control of the classically known major risk factors of infections, in routine procedures involving a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled.
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Nov 2017
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every patient undergoing a cardiac procedure with sternotomy, including coronary artery bypass, " , aortic surgery, or combined procedures, scheduled or on emergency, under extracorporeal circulation or not.
Who may be able to join
- patient aged more than 18 yards old,
- sternotomy for one of the following procedures : coronary artery bypass, valvuloplasty, aortic surgery, combination of the mentioned interventions.
- without considering the degree on emergency and the presence of extra corporeal circulation.
Who cannot join
- patient under age or 18years old.
- patient not informed.
- surgical revision in case of suspicion of infection, haemorragic complication, suspicion of myocardial infarction.
- endocarditis indicating a valvuloplasty procedure.
- patient who underwent orthopedic surgery with prothetic material, within the 12 months preceeding cardiac procedure.
Trial locations and contacts
No sites are listed yet.
About this study
There is a recent increase in incidence of surgical site infection after cardiac surgery in our hospital, in spite of specific measures taken concerning some aspects of the surgical procedures, targeting a better control of the classically known major risk factors of infections, in routine procedures involving a sternotomy such as coronary artery bypass graft, valvuloplasty, aortic surgery, or combined procedures.
The first objective of this monocentric prospective cohort study, is to evaluate underestimated specific risk factors of surgical site infection, during the perioperative period, for patients undergoing cardiac surgery with sternotomy.
Read more
Secondly, to estimate the specific risk associated with each class or micro-organisms responsible, and their profile of resistance.
The outcomes concern the occurrence of a surgical site infection diagnosed by the surgeon in charge of the patient, one month and three months after surgery; it may concern the pre operative period, the procedure itself, or the early post operative period, characterized by a high density of cares, or even the late rehabilitation, after discharge of the surgical unit.
Secondary outcome evaluate the profile of agents identified regarding the susceptibility of the prophylaxis recommended to prevent wound infection; it may suggest that an adequate antibiotic prophylaxis is often insufficient to take into account the responsible agents, and that decolonisation is not always that helpful, in view of emerging cases of failure due to developing resistance.
Considering the low incidence of that type of complication, the investigators estimated that a period of two years might be necessary to include a sufficient number of patient, at least one thousand, in order to find a dozen of factors that might be significantly associated with an increased risk of surgical site infection.
The evaluation is permitted by the collaboration between the anesthesiologists, surgeons, intensivists, hygienists, all along the presence of the patient in the department, until discharge out of the hospital and after readmission eventually for infectious complication.
Read the detailed description
Surgical site infection following cardiac surgery is source of a significant morbidity and mortality. It may occur in patients who present preexisting fragilizing underlying conditions, and who suffer a major surgical traumatism, considering the sternotomy, the presence of an eventual extracorporeal circulation, the bleeding risk associated to the procedure, hypothermia, etc.
Many risk factors have already been studied, and might be targeted by prevented measures.
Some of them concern the pre-operative period, related to the patient's underlying conditions, the disinfection and eventual decolonisation of the patients; some concern the procedure intrinsically, according to the surgical technique preferred; an important role may be accorded to the post-operative period, during which a high density of care might be responsible of an eventual contamination, recolonisation, or fragilisation of the patients, thus making them more susceptible to infection.
Despite the control of the modifiable risk factors and the application of preventive measures, we are facing a progressive increasing in surgical site infection since a few months.
We aim to prospectively and exhaustively evaluate all the risk factors that can play a role before, during or after the surgical period, in the routine procedures involving a sternotomy, including coronary artery bypass graft, valvuloplasty (except for endocarditis), thoracic aortic surgery, and combined procedures, without considering the degree of emergency, the presence of an extracorporeal membrane, in every major adult admitted in the department of cardiothoracic surgery.
Those events can be related to the contemporary increased activity in the department of cardiothoracic surgery. This hypothesis was advanced as an explanation, but the growing number of patients operated during the last months couldn't be the only factor responsible of the post-operative infectious complications. Moreover, microbiological epidemiology does not simply allow a single targeted preventive strategy because there is no particular agent responsible of these infections, and the bacterial populations are globally comparable to the classical ones identified in this type of surgery. It is including of large majority of gram positive cocci, essentially Staphylococcus aureus (in which we find a quasi absence of methicillin-resistance) and epidermis, and a significant prevalence of gram negative bacilli. So there is no evidence of an epidemic recrudescence linked to a specific microbiological element that could be easily identified.
Nevertheless, the recommended prophylaxis deserve to be reconsidered, regarding the overall emergence in every class of microbial agents, which constitute a real problem that have to face each intensive care unit; thus, it seems logical to consider that the same protocol applied during several years may lose in efficacy while the epidemiology of resistance is in constant and accelerating evolution. So the microbial agents could be identical as those classically identified, so may not their susceptibility. At least, we might consider an eventual modification of our choices in which prophylaxis should be administered.
The evaluation starts preoperatively after information of the eligible patients, at the admission in the cardiothoracic department, while it can also be initiated during the preoperative anesthaesic evaluation. In all case, a moment before admission in operating room should be dedicated by a resident in surgery or anesthesiolgy to recense the pre existing conditions.
Then the time of the procedure may involve different actors (perfusionist, all member of the anesthesiologic team, surgeons) to examine each step of the procedure, pre-established on a checklist to which every one has access (informed file for each patient who enter the operating room).
After surgery, the cares occur in a dedicated unit as long as the patient's status justify intensive monitoring, often invasive, and eventual appropriate suppliance mediated by drugs or devices according to intensivist praticians in charge, surgeon or anesthesiologist, the procedure and the patient's tolerance.
As early as possible, the discharge of this unit is decided to pursuit in a conventional sector, where the patient is in charge of the surgical staff only, with a more moderate surveillance but to permit an early rehabilitation, before discharge of the hospital, towards a rehabilitation facility, and then return at home.
The follow-up is commonly accomplished by all the actors taking part in the operating room, and after in the intensive care unit. But during hospitalisation or after discharge, it is the surgeons' role to diagnose and declare to hygienists all the infectious complications that might be considered as surgical site infection. In case of re-admission for complications, the hygienist staff should also receive such a declaration.
In order to collect exhaustively all the interesting variables before, during and after surgery, for a period potentially prolonged until 3months, one member of the anesthesiologist staff is in charge to audit the follow-up in every care unit inside hospital from admission until discharge, and also after check if an eventual event occurred, with the hygienists informed of that event.
An ancillary study might next be conducted, in order to evaluate the pharmacokinetic of antibiotic prophylaxis for patient under extracorporeal circulation. It might eventually study the modality of continuous administration over a prolonged time during surgery; it might include blood samples during procedure and immediately after for repeated antibiotic dosages.
Sites were blood sample is taken can be extracorporeal circulation or catheter used for routine monitoring, such as radial artery catheter, for invasive blood pressure monitoring, which is a constant mean of surveillance peroperatively and after surgery in intensive care unit.
So this procedure does not implicate further invasive manipulations that are not already in part of the routine standard cares.
- Conditions
- Surgical Site Infection
- Being tested
- Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled.
- Keywords
- according to the definition of the Comité Technique des Infections Nosocomiales et Liées aux Soins (2007)
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled.Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site infection
Diagnostic made by the surgeon in charge of the patient, according to the criterias suggested by the CTINLS, on clinical or paraclinical elements.
The occurrence during the first month may point out a potential interest of an intervention on a short term period (during and after surgery), concerning the cares administered inside the department of cardiothoracic surgery.
Measured: 30 days after surgery
Surgical Site Infection
Diagnostic made by the surgeon in charge of the patient, according to the criterias suggested by the CTINLS, on clinical or paraclinical elements.
The occurence of a delayed diagnosis may suggest a late infection, involving an intervention during and after the rehabiliation, outside the departement of cardiothoracic surgery.
Some elements may concern the surgical period, but my be revealed several weeks after the discharge of the patient.
Measured: 90 days after surgery
Secondary outcomes (2)
Bacterial Phenotype regarding the molecule administered as prophylaxis or decontamination preoperatively or during the procedure.
The bacterial agent, causing the surgical site infection, susceptibility or resistance towards the antibiotic prophylaxis and the decontamination agents.
Accurately, the susceptibility to mupirocin, cefuroxime, and vancomycin can vary and explain an early and agressive developement in the wound site.
Measured: 30 days after surgery
Bacterial Phenotype regarding the molecule administered as prophylaxis or decontamination preoperatively or during the procedure.
The bacterial agent, causing the surgical site infection, susceptibility or resistance towards the antibiotic prophylaxis and the decontamination agents.
Accurately, the susceptibility to mupirocin, cefuroxime, and vancomycin can vary and allow a low and delayed developement in the wound region.
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul-Henri WICKY, Centre Hospitalier Universitaire de Besancon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392936
- Sponsor's protocol ID
- CHU Besancon
- Acronym
- PRISCCA
- Status last verified
- Mar 2015
- First submitted
- 4 Mar 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peri-operative Risk Factors for Surgery Site Infection in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02392936
- Acronym / sponsor ID
- PRISCCA / CHU Besancon
- Conditions
- Surgical Site Infection
- Keywords
- according to the definition of the Comité Technique des Infections Nosocomiales et Liées aux Soins (2007)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 19 Mar 2015 (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.
There is a recent increase in incidence of surgical site infection after cardiac surgery in our hospital, in spite of specific measures taken concerning some aspects of the surgical procedures, targeting a better control of the classically known major risk factors of infections, in routine procedures involving a sternotomy such as coronary artery bypass graft, valvuloplasty, aortic surgery, or combined procedures.
The first objective of this monocentric prospective cohort study, is to evaluate underestimated specific risk factors of surgical site infection, during the perioperative period, for patients undergoing cardiac surgery with sternotomy.
Secondly, to estimate the specific risk associated with each class or micro-organisms responsible, and their profile of resistance.
The outcomes concern the occurrence of a surgical site infection diagnosed by the surgeon in charge of the patient, one month and three months after surgery; it may concern the pre operative period, the procedure itself, or the early post operative period, characterized by a high density of cares, or even the late rehabilitation, after discharge of the surgical unit.
Secondary outcome evaluate the profile of agents identified regarding the susceptibility of the prophylaxis recommended to prevent wound infection; it may suggest that an adequate antibiotic prophylaxis is often insufficient to take into account the responsible agents, and that decolonisation is not always that helpful, in view of emerging cases of failure due to developing resistance.
Considering the low incidence of that type of complication, the investigators estimated that a period of two years might be necessary to include a sufficient number of patient, at least one thousand, in order to find a dozen of factors that might be significantly associated with an increased risk of surgical site infection.
The evaluation is permitted by the collaboration between the anesthesiologists, surgeons, intensivists, hygienists, all along the presence of the patient in the department, until discharge out of the hospital and after readmission eventually for infectious complication.
Detailed description
Surgical site infection following cardiac surgery is source of a significant morbidity and mortality. It may occur in patients who present preexisting fragilizing underlying conditions, and who suffer a major surgical traumatism, considering the sternotomy, the presence of an eventual extracorporeal circulation, the bleeding risk associated to the procedure, hypothermia, etc.
Many risk factors have already been studied, and might be targeted by prevented measures.
Some of them concern the pre-operative period, related to the patient's underlying conditions, the disinfection and eventual decolonisation of the patients; some concern the procedure intrinsically, according to the surgical technique preferred; an important role may be accorded to the post-operative period, during which a high density of care might be responsible of an eventual contamination, recolonisation, or fragilisation of the patients, thus making them more susceptible to infection.
Despite the control of the modifiable risk factors and the application of preventive measures, we are facing a progressive increasing in surgical site infection since a few months.
We aim to prospectively and exhaustively evaluate all the risk factors that can play a role before, during or after the surgical period, in the routine procedures involving a sternotomy, including coronary artery bypass graft, valvuloplasty (except for endocarditis), thoracic aortic surgery, and combined procedures, without considering the degree of emergency, the presence of an extracorporeal membrane, in every major adult admitted in the department of cardiothoracic surgery.
Those events can be related to the contemporary increased activity in the department of cardiothoracic surgery. This hypothesis was advanced as an explanation, but the growing number of patients operated during the last months couldn't be the only factor responsible of the post-operative infectious complications. Moreover, microbiological epidemiology does not simply allow a single targeted preventive strategy because there is no particular agent responsible of these infections, and the bacterial populations are globally comparable to the classical ones identified in this type of surgery. It is including of large majority of gram positive cocci, essentially Staphylococcus aureus (in which we find a quasi absence of methicillin-resistance) and epidermis, and a significant prevalence of gram negative bacilli. So there is no evidence of an epidemic recrudescence linked to a specific microbiological element that could be easily identified.
Nevertheless, the recommended prophylaxis deserve to be reconsidered, regarding the overall emergence in every class of microbial agents, which constitute a real problem that have to face each intensive care unit; thus, it seems logical to consider that the same protocol applied during several years may lose in efficacy while the epidemiology of resistance is in constant and accelerating evolution. So the microbial agents could be identical as those classically identified, so may not their susceptibility. At least, we might consider an eventual modification of our choices in which prophylaxis should be administered.
The evaluation starts preoperatively after information of the eligible patients, at the admission in the cardiothoracic department, while it can also be initiated during the preoperative anesthaesic evaluation. In all case, a moment before admission in operating room should be dedicated by a resident in surgery or anesthesiolgy to recense the pre existing conditions.
Then the time of the procedure may involve different actors (perfusionist, all member of the anesthesiologic team, surgeons) to examine each step of the procedure, pre-established on a checklist to which every one has access (informed file for each patient who enter the operating room).
After surgery, the cares occur in a dedicated unit as long as the patient's status justify intensive monitoring, often invasive, and eventual appropriate suppliance mediated by drugs or devices according to intensivist praticians in charge, surgeon or anesthesiologist, the procedure and the patient's tolerance.
As early as possible, the discharge of this unit is decided to pursuit in a conventional sector, where the patient is in charge of the surgical staff only, with a more moderate surveillance but to permit an early rehabilitation, before discharge of the hospital, towards a rehabilitation facility, and then return at home.
The follow-up is commonly accomplished by all the actors taking part in the operating room, and after in the intensive care unit. But during hospitalisation or after discharge, it is the surgeons' role to diagnose and declare to hygienists all the infectious complications that might be considered as surgical site infection. In case of re-admission for complications, the hygienist staff should also receive such a declaration.
In order to collect exhaustively all the interesting variables before, during and after surgery, for a period potentially prolonged until 3months, one member of the anesthesiologist staff is in charge to audit the follow-up in every care unit inside hospital from admission until discharge, and also after check if an eventual event occurred, with the hygienists informed of that event.
An ancillary study might next be conducted, in order to evaluate the pharmacokinetic of antibiotic prophylaxis for patient under extracorporeal circulation. It might eventually study the modality of continuous administration over a prolonged time during surgery; it might include blood samples during procedure and immediately after for repeated antibiotic dosages.
Sites were blood sample is taken can be extracorporeal circulation or catheter used for routine monitoring, such as radial artery catheter, for invasive blood pressure monitoring, which is a constant mean of surveillance peroperatively and after surgery in intensive care unit.
So this procedure does not implicate further invasive manipulations that are not already in part of the routine standard cares.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient undergoing a cardiac procedure with sternotomy, including coronary artery bypass, " , aortic surgery, or combined procedures, scheduled or on emergency, under extracorporeal circulation or not.
Key inclusion criteria (3 listed)
- patient aged more than 18 yards old,
- sternotomy for one of the following procedures : coronary artery bypass, valvuloplasty, aortic surgery, combination of the mentioned interventions.
- without considering the degree on emergency and the presence of extra corporeal circulation.
Key exclusion criteria (5 listed)
- patient under age or 18years old.
- patient not informed.
- surgical revision in case of suspicion of infection, haemorragic complication, suspicion of myocardial infarction.
- endocarditis indicating a valvuloplasty procedure.
- patient who underwent orthopedic surgery with prothetic material, within the 12 months preceeding cardiac procedure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled. | Procedure or surgery | – |
Primary outcome
Surgical Site infection
Time frame: 30 days after surgery
Diagnostic made by the surgeon in charge of the patient, according to the criterias suggested by the CTINLS, on clinical or paraclinical elements. The occurrence during the first month may point out a potential interest of an intervention on a short term period (during and after surgery), concerning the cares administered inside the department of cardiothoracic surgery.
Surgical Site Infection
Time frame: 90 days after surgery
Diagnostic made by the surgeon in charge of the patient, according to the criterias suggested by the CTINLS, on clinical or paraclinical elements. The occurence of a delayed diagnosis may suggest a late infection, involving an intervention during and after the rehabiliation, outside the departement of cardiothoracic surgery. Some elements may concern the surgical period, but my be revealed several weeks after the discharge of the patient.
2 secondary outcomes
Bacterial Phenotype regarding the molecule administered as prophylaxis or decontamination preoperatively or during the procedure.
Time frame: 30 days after surgery
Bacterial Phenotype regarding the molecule administered as prophylaxis or decontamination preoperatively or during the procedure.
Time frame: 90 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
Related trials for Surgical Site Infection
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by Centre Hospitalier Universitaire de Besancon.
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 3 inclusion and 5 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 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Paul-Henri Wicky (0033-680-129-209, phwicky@outlook.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site infection (time frame: 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2015.