Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04129177 |
| Other study ID # |
HGranollers |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2018 |
| Est. completion date |
June 30, 2020 |
Study information
| Verified date |
March 2023 |
| Source |
Hospital de Granollers |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Background. The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors SSI
in elective colorectal surgery since 2007 in 56 hospitals (7.5 million population). These
hospitals perform active and prospective standardized surveillance of elective colorectal
resections. Post-discharge surveillance is mandatory up to 30 days after surgery. Between
2007 and 2015, the SSI rate did not change significantly, with a cumulated incidence of 5,491
SSI in a total of 29,006 interventions (19%). In 2015, a working group of VINCat specialists
and surgeons from the Catalan Society of Surgery was set up to formulate a specific bundle of
SSI preventative measures for colorectal surgery.
Aim. To analyse the effect of a specific bundle for SSI prevention in elective colorectal
surgery.
Methods. In 2016, a bundle of six preventative measures was recommended to the VINCat
hospitals. Bundle measures were: systemic and oral antibiotic prophylaxis, mechanical bowel
preparation (MBP), laparoscopic surgery, maintenance of normothermia, and the use of a
double-ring wound retractor. The results of SSI before and after the implementation of the
bundle are compared. The results are analysed using the chi-square test (statistical
significance p <0.05).
Description:
Surgical location infection (ILQ) is the most frequent complication of surgery and an
important source of clinical and economic problems for health systems. The reduction of its
incidence is important because of its impact on patient comfort and the health resources
used. The ILQ includes the categories of: superficial incisional (IIS, affects skin and
subcutaneous tissue); deep incisional (IIP, affects deep soft tissues), and organ-space or
organ-cavitary (IOE, affects any anatomical structure other than the incision manipulated
during the intervention). Surgical procedures are distributed in the categories of clean,
clean-contaminated, contaminated and dirty or infected surgery depending on your risk of ILQ.
Elective colorectal surgery belongs to the clean-contaminated surgery category, it is one of
the most frequent surgical procedures in Western society and the one with the highest rate of
postoperative infection. The ILQ after colorectal procedures represents a measurable
indicator of the quality of a health system. Endogenous factors of the patient and exogenous
factors related to the surgical procedure are involved in the development of the ILQ.
Despite the introduction of laparoscopy and the standardization of perioperative measures of
prophylaxis, the clean-contaminated nature of these procedures, the increase in comorbidities
and age of patients and the increase in the complexity of surgical procedures do not improve
the Postoperative ILQ rates. It is necessary to investigate the usefulness of complementary
prophylactic measures that allow lowering the level of wound contamination and reducing the
rate of ILQ.
The grouping of ILQ prevention measures into bundles or packages of measures with a high
level of evidence is a strategy that has proven effective in various types of surgical
procedures. The overall effectiveness of a package of measures depends on the degree of
individual effectiveness of each of the measures included in the bundle.
The Nosocomial Infection Surveillance Program in Catalonia (VINCat) has been monitoring ILQ
rates in elective colorectal surgery since 2007 in 55 hospitals. These hospitals perform
active and prospective standardized surveillance of elective colorectal resections.
Post-discharge surveillance is mandatory up to 30 days after surgery. Between 2007 and 2015,
the rate of ILQ did not change significantly, with a cumulative incidence of 5,491 ILQ in a
total of 29,006 interventions (19%). Given the persistence of these infection rates, in 2015,
an interdisciplinary working group was formed that included infection control nurses,
infectious disease specialists, anesthetists and surgeons of the Catalan Society of Surgery.
Its objective was to design a specific package of ILQ preventive measures for elective
colorectal surgery that could affect the incisional infection and organ / space.
In 2016, a package of 6 measures of prevention of ILQ in colorectal surgery was implanted in
hospitals belonging to VINCat.
Ambit. A multicenter study is proposed in 55 hospitals in Catalonia. This is a cohort study
of the prospective VINCat database, which collects data on surgical patients with the purpose
of improving quality. Sixty-five VINCat hospitals participate in the surveillance of ILQ in
colorectal surgery, an effort focused on improving the ILQ in colon and rectal operations
since 2007. There are more than 43,000 case records since that date. VINCat hospitals are
predominantly public hospitals.
Workgroup. The working group is multicentre and interdisciplinary, including doctors and
nurses of different specialties related to the prevention and control of surgical infection
(surgical nursing, anesthesia, infectious diseases, infection spread and surgery) of
different hospitals in the territory. The working group has a long experience in the
surveillance and prevention of nosocomial and surgical infection and with the necessary means
to carry out the project.
Recipients The study recipients are all patients undergoing elective colorectal surgery, one
of the most frequent major abdominal surgical procedures in our hospitals and one of the ones
that causes the most complications and health costs.
Hypothesis. Implantation of a package of ILQ prevention measures in colorectal surgery, which
includes the combination of oral antibiotic and mechanical colon preparation (PMC) may
decrease the rate of ILQ in elective colon surgery.
Goals. Principal. Evaluate the effect of the implementation of a package of specific measures
(bundle) in reducing the ILQ rate
