Colon CancerCCR-VINCat2NCT06244836
Comparison of Two Bundles of Care to Reduce Surgical Site Infection in Colorectal Surgery (CCR-VINCat 2)
A study testing Implementation of a bundle of care in people with Colon Cancer and Rectal Cancer, run by Hospital de Granollers at 1 site in Spain.
Trial summary
There is controversy about the maximum number of elements to be included in a surgical site infection (SSI) prevention bundle and the possibility of its implementation at a multi-center level. This study analyzes SSI rates in colorectal surgery after the implementation of two preventive bundles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Surgical Site Infection
- What is being tested?
- Implementation of a bundle of care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32,205 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2011to 31 Jan 2023
- Phase
- Interventional
- 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
Who may be able to join
- Colon or rectal elective surgery.
Who cannot join
- Peritonitis at the time of intervention ("dirty" surgery) Patients who underwent multiple procedures during the same surgery, for example resection of liver metastases Centers that performed less tan 10 surgical procedures annually Centers that have not been able to ensure prospective surveillance during hospitalization or effective monitoring of cases within 30 days of the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Postoperative Infection Prevention Bundles in Colorectal Surgery. A Pragmatic Multicenter Cohort Study.
There is controversy about the maximum number of elements to be included in a surgical site infection (SSI) prevention bundle and the possibility of its implementation at a multi-center level.
This study analyzes SSI rates in colorectal surgery after the implementation of two preventive bundles.
The investigators hypothesized that the thorough introduction of a well-designed large bundle of best practice preventive measures would result in good adherence and greater reduction of SSI rates after colorectal surgery.
Read the detailed description
To better understand the impact of adding new measures to an established bundle within a national surveillance program and to measure the effectiveness of each specific measures, the effect of a six-measure and a ten-measure bundle sequentially implemented on a large series of elective colorectal procedures from 2011 to 2022 was analized. In addition, it will be investigated whether taking advantage of a national surveillance programme for post-operative infections can facilitate the implementation of the packages.
Setting and patients. This is a pragmatic, cohort, multicentre study of a network of 65 public and private hospitals prospectively collecting data from elective colorectal surgery to minimise surgical site infection (SSI) rates and improve care. Prospective surveillance is conducted by each hospital's infection control team to ensure adequate data collection with a mandatory minimum follow-up of 30 days after surgery and electronic chart review checking readmissions, emergency department visits, microbiological and radiological data.
Patients undergoing elective colorectal surgery between January 2011 and December 2022 will be included. Cases with class 2 (clean-contaminated) and 3 (contaminated) wounds, according to the National Healthcare Safety Network classification, will be followed up. Patients with class 4 wounds (peritonitis) and previous ostomies are excluded.
Three sequential phases will be compared: a baseline period before package implementation (Baseline Group), from January 2011 to June 2016; a Bundle-1 period after implementation of a package of six measures (Bundle-1 Group), from July 2016 to June 2018; and a Bundle-2 period after implementation of a package of ten measures (Bundle-2 Group), from July 2018 to December 2022.
Definitions, study results and variables. The SSIs are defined according to the definitions of the Centers for Disease Control and Prevention.
The primary objective will be to analyse the effect of the implementation of the package on the prevention of SSIs and their subtypes and to assess compliance and effectiveness of individual measures. Secondary outcomes will be length of stay, mortality and micro-organisms causing SSIs.
Intervention. In the Reference Group, some measures such as intravenous antibiotic prophylaxis and the use of laparoscopy were included as standard clinical practice. In Bundle-1, six well-documented colorectal-specific measures were introduced: intravenous antibiotic prophylaxis, laparoscopy, oral antibiotic prophylaxis, mechanical bowel preparation, normothermia and double-ring plastic wound retractor. In Bundle-2, four additional general measures were incorporated in addition to the above: adequate depilation, skin antisepsis with 2% chlorhexidine gluconate in alcohol, perioperative glucose control and instrument change before wound closure.
- Conditions
- Colon Cancer, Rectal Cancer, Surgical Site Infection
- Being tested
- Implementation of a bundle of care
- Keywords
- Surveillance, Surgical site infection, Colorectal surgery, Prevention, Preventive measures, Bundle of care
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of a bundle of careOther
| Study group | Role | What they receive |
|---|---|---|
| Baseline group | No intervention | Patients included in the Catalan Nosocomial Infection surveillance Program (VINCat) program, and operated on colorectal surgery before bundle implementation, from January 2011 to June 2016 |
| Implementation of a six-measures Bundle-1 (Bundle 1 Group) | Experimental | Bundle-1 period after the implementation of a six-measure bundle, from July 2016 to June 2018 Receives: Other: Implementation of a bundle of care |
| Implementation of a ten-measures Bundle-2 (Bundle 2 Group) | Experimental | Bundle-2 period after the implementation of a ten-measure bundle, from July 2018 to December 2022 Receives: Other: Implementation of a bundle of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection (SSI) incidence within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
Overall surgical site infection (SSI) rate will be defined as any infection originating in surgical wounds or the organs/spaces opened or manipulated during an operative procedure. The incidence of SSI will be measured as events per 100 procedures included.
Measured: 30 days
Secondary outcomes (2)
Organ/space surgical infection rate within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
Specific organ/space surgical infection (O/S-SSI) rate. O/S-SSI is the infection that involves any part of the anatomy in organs and spaces other than the incision, which is opened or manipulated during operation. he incidence of O/S-SSI will be measured as events per 100 procedures included.
Measured: 30 days
Hospital type-Surgical infection rate within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
Comparison of SSIs rates among the three hospitals groups, according to their size. The hospitals are classified into three groups according to their complexity and number of hospital beds: >500 beds; 200-500 beds; ≤200 beds.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Jan 2011
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study compare three phases: a baseline period before bundle implementation (Baseline Group), from January 2011 to June 2016; a Bundle-1 period after the implementation of a six-measure bundle (Bundle-1 Group), from July 2016 to June 2018; and a Bundle-2 period after the implementation of a ten-measure bundle (Bundle-2 Group), from July 2018 to December 2022
- Masking
- None (open label)
- Enrolment
- 32,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Josep M Badia, MD, PhD, Principal investigator, Hospital General de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244836
- Sponsor's protocol ID
- CCR-VINCat2
- Acronym
- CCR-VINCat2
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared if requested
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Postoperative Infection Prevention Bundles in Colorectal Surgery. A Pragmatic Multicenter Cohort Study.
- ClinicalTrials.gov ID
- NCT06244836
- Acronym / sponsor ID
- CCR-VINCat2 / CCR-VINCat2
- Conditions
- Colon Cancer, Rectal Cancer, Surgical Site Infection
- Keywords
- Surveillance, Surgical site infection, Colorectal surgery, Prevention, Preventive measures, Bundle of care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32,205 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 6 Feb 2024 (actual)
- 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 controversy about the maximum number of elements to be included in a surgical site infection (SSI) prevention bundle and the possibility of its implementation at a multi-center level.
This study analyzes SSI rates in colorectal surgery after the implementation of two preventive bundles.
The investigators hypothesized that the thorough introduction of a well-designed large bundle of best practice preventive measures would result in good adherence and greater reduction of SSI rates after colorectal surgery.
Detailed description
To better understand the impact of adding new measures to an established bundle within a national surveillance program and to measure the effectiveness of each specific measures, the effect of a six-measure and a ten-measure bundle sequentially implemented on a large series of elective colorectal procedures from 2011 to 2022 was analized. In addition, it will be investigated whether taking advantage of a national surveillance programme for post-operative infections can facilitate the implementation of the packages.
Setting and patients. This is a pragmatic, cohort, multicentre study of a network of 65 public and private hospitals prospectively collecting data from elective colorectal surgery to minimise surgical site infection (SSI) rates and improve care. Prospective surveillance is conducted by each hospital's infection control team to ensure adequate data collection with a mandatory minimum follow-up of 30 days after surgery and electronic chart review checking readmissions, emergency department visits, microbiological and radiological data.
Patients undergoing elective colorectal surgery between January 2011 and December 2022 will be included. Cases with class 2 (clean-contaminated) and 3 (contaminated) wounds, according to the National Healthcare Safety Network classification, will be followed up. Patients with class 4 wounds (peritonitis) and previous ostomies are excluded.
Three sequential phases will be compared: a baseline period before package implementation (Baseline Group), from January 2011 to June 2016; a Bundle-1 period after implementation of a package of six measures (Bundle-1 Group), from July 2016 to June 2018; and a Bundle-2 period after implementation of a package of ten measures (Bundle-2 Group), from July 2018 to December 2022.
Definitions, study results and variables. The SSIs are defined according to the definitions of the Centers for Disease Control and Prevention.
The primary objective will be to analyse the effect of the implementation of the package on the prevention of SSIs and their subtypes and to assess compliance and effectiveness of individual measures. Secondary outcomes will be length of stay, mortality and micro-organisms causing SSIs.
Intervention. In the Reference Group, some measures such as intravenous antibiotic prophylaxis and the use of laparoscopy were included as standard clinical practice. In Bundle-1, six well-documented colorectal-specific measures were introduced: intravenous antibiotic prophylaxis, laparoscopy, oral antibiotic prophylaxis, mechanical bowel preparation, normothermia and double-ring plastic wound retractor. In Bundle-2, four additional general measures were incorporated in addition to the above: adequate depilation, skin antisepsis with 2% chlorhexidine gluconate in alcohol, perioperative glucose control and instrument change before wound closure.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study compare three phases: a baseline period before bundle implementation (Baseline Group), from January 2011 to June 2016; a Bundle-1 period after the implementation of a six-measure bundle (Bundle-1 Group), from July 2016 to June 2018; and a Bundle-2 period after the implementation of a ten-measure bundle (Bundle-2 Group), from July 2018 to December 2022
| Arm | Type | Receives |
|---|---|---|
| Baseline group | No intervention | –Patients included in the Catalan Nosocomial Infection surveillance Program (VINCat) program, and operated on colorectal surgery before bundle implementation, from January 2011 to June 2016 |
| Implementation of a six-measures Bundle-1 (Bundle 1 Group) | Experimental | Other: Implementation of a bundle of careBundle-1 period after the implementation of a six-measure bundle, from July 2016 to June 2018 |
| Implementation of a ten-measures Bundle-2 (Bundle 2 Group) | Experimental | Other: Implementation of a bundle of careBundle-2 period after the implementation of a ten-measure bundle, from July 2018 to December 2022 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Colon or rectal elective surgery.
Key exclusion criteria (1 listed)
- Peritonitis at the time of intervention ("dirty" surgery) Patients who underwent multiple procedures during the same surgery, for example resection of liver metastases Centers that performed less tan 10 surgical procedures annually Centers that have not been able to ensure prospective surveillance during hospitalization or effective monitoring of cases within 30 days of the intervention
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 |
|---|---|---|
| Implementation of a bundle of care | Other | Implementation of a six-measures Bundle-1 (Bundle 1 Group), Implementation of a ten-measures Bundle-2 (Bundle 2 Group) |
Primary outcome
Surgical site infection (SSI) incidence within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
Time frame: 30 days
Overall surgical site infection (SSI) rate will be defined as any infection originating in surgical wounds or the organs/spaces opened or manipulated during an operative procedure. The incidence of SSI will be measured as events per 100 procedures included.
2 secondary outcomes
Organ/space surgical infection rate within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
Time frame: 30 days
Hospital type-Surgical infection rate within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No. Data will be shared if requested
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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.
Josep M Badia, MD, PhD principal investigator
Hospital General de Granollers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of a bundle of care in people with Colon Cancer and Rectal Cancer, run by Hospital de Granollers at 1 site in Spain.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Feb 2024. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (SSI) incidence within 30 days of surgery according to the Centers for Disease Control and Prevention (CDC) criteria. (time frame: 30 days). 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 6 Feb 2024.