Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06244836 |
| Other study ID # |
CCR-VINCat2 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2011 |
| Est. completion date |
January 31, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Hospital de Granollers |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
