Reduction of Surgical Site Infections in Elective Colorectal Surgery After the Implementation of a Bundle of Care.

NCT04129177 | Completed DMC

• 1 other identifier: HGranollers
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colorectal Neoplasms; Surgical Wound Infection

Keywords

Surgical site infection; Colorectal surgery; Surveillance; Bundle approach

Outcome Measures

Primary Outcomes (1)

• Surgical site infection rate

  Rate of Surgical site infection according to the definitions of the CDC-NHSN (Centers for Disease Control and Prevention-National Healthcare Safety Network)

  30 days

Interventions

Implementation of a bundle of surgical infection preventive measures OTHER

A bundle of six preventative measures is 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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective colorectal surgery in Catalonia in the period 2012-2018

You may qualify if:

• Elective colorectal resection

You may not qualify if:

• Emergency surgery - Infection present at operation

Sponsors & Collaborators

• Hospital de Granollers: lead

Study Sites (1)

Fundació Privada Hospital Asil de Granollers

Granollers, Barcelona, 08402, Spain

Location

Related Publications (1)

• Badia JM, Arroyo-Garcia N, Vazquez A, Almendral A, Gomila-Grange A, Fraccalvieri D, Pares D, Abad-Torrent A, Pascual M, Solis-Pena A, Puig-Asensio M, Pera M, Gudiol F, Limon E, Pujol M; Members of the VINCat Colorectal Surveillance Team; VINCat Program*. Leveraging a nationwide infection surveillance program to implement a colorectal surgical site infection reduction bundle: a pragmatic, prospective, and multicenter cohort study. Int J Surg. 2023 Apr 1;109(4):737-751. doi: 10.1097/JS9.0000000000000277.

  PMID: 36917127 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of surgical infection department

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 16, 2019
• Study Start: October 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2020
• Last Updated: October 4, 2024

Record last verified: 2024-10

Locations

ES (1)