Observation of the Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully

Reduction of Surgical Site Infections in Colorectal Surgery Clinical Trial

Official title:

Observation of the Implementation of a Bundle of Care in Colorectal Surgery to Reduce Surgical Site Infections Successfully

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04677686
• Other study ID #: 220-00051
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2020
• Source: Luzerner Kantonsspital
• Contact: Jörn-Markus Gass
• Phone: 0041412854835
• Email: markus.gass[@]luks.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate whether the colorectal bundle designed and implemented at Cantonal Hospital Lucerne, will lead to a significant reduction of SSIs. The impact of potential risk factors for SSIs will additionally be evaluated.

Description:

Surgical site infections (SSIs) remain a relevant problem in colorectal surgery. The aim of this study is to implement a bundle of care in order to reduce SSIs in colorectal surgery.

All patients undergoing colorectal surgery between October 2018 and September 2021 will be included in a prospective observational study. Since our colorectal bundle has been established gradually, patients will be grouped in a pre-implementation (2018-2019), implementation (2019-2020) and post implementation phase (2020-2021), in order to assess the effectiveness of the actions undertaken. Primary endpoint of this study will be surgical site infection (SSI) rate, while secondary endpoints encompass potential risk factors for SSIs. We assume that obesity, age, diabetes, alcoholism and smoking may lead to a higher risk for SSIs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

over 18 elective or emergency colorectal surgery written informed consent

Exclusion Criteria:

pregnant no informed consent

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Reduction of Surgical Site Infections in Colorectal Surgery
• Surgical Wound Infection

Intervention

Behavioral:
• Bundle of Care
Hair removal with Clipper Glucose Control Preoperative antibiotics Repeat antibiotics after 4 Hours Optimize Body temperature Instrument change for colorectal anastomosis Use of wound protectors Experienced surgeon Preoperative showering

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital of Lucerne	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site infection	rate of SSIs and classification of SSIs (superficial SSI, deep SSI or organ space SSI)	30 days
Secondary	Risk factors for SSI	Determination of the risk factors for SSI (Obesity, age, diabetes, alcoholism, immune-deficit illnesses (such as HIV and Hepatitis), smoking, immunosuppressive drugs, chemotherapy, radiotherapy, COPD, pAVK, renal insufficiency and poor Nutrition)	at surgery