Changing the Surgical Team for Wound Closure and Surgical Site Infection

Morality Clinical Trial

Official title:

Impact of Changing the Surgical Team for Wound Closure on Surgical Site Infection: a Matched Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503642
• Other study ID #: CLOT-T trial
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: August 2020
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Surgical site infection is a frequent complication after abdominal surgery. The wound closure is done at the end of the procedure when the attention of the entire team may be affected because of tiredness and reduced attention of the surgical team.

With this study, the investigators aim to test if an exchange of the surgical team by a specialised wound closure team may reduce the impact of surgical site infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1160
• Est. completion date: February 28, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• General Consent as documented by signature

• Patients undergoing elective or emergency abdominal surgery from Monday to Friday with wound closure from 8:00 until 17:30 and duration of operation.

• Age over 18 years

Exclusion Criteria:

• Patients < 18 years of age

• Patients with preexisting SSI

Related Conditions & MeSH terms

• Communicable Diseases
• Fascial Hernia
• Incidence of Surgical Site Infection
• Infection
• Morality
• Surgical Wound Infection

Intervention

Procedure:
• Changing the surgical team for wound closure
The intervention consists of the exchange of the primary surgical team with a second surgical team that consists of one surgeon and one student. The first surgical team then may leave the operation theatre but is continuously accessible for questions.

Locations

Country	Name	City	State
Switzerland	Dep. of Visceral and transplant surgery, Berne University Hospital	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with SSIs	SSI that occur after surgery will be assessed according to the criteria developed by the Centers for Disease Control and Prevention. Infections will be categorized as incisional (superficial or deep) infections or organ-space infections. Superficial SSI (type 1) involve only skin and subcutaneous tissue and exclude stitch abscesses. Deep SSI (type 2) involve deeper soft tissues, like fascia and muscle, at the site of incision. Organ-space SSI (type 3) involve any organ or body cavity	30 days postoperative
Secondary	Mortality	Postoperative Mortality at 30 days	30 days postoperative
Secondary	Numbers of patients with fascial dehiscence at 30 days postoperative		30 days postoperative
Secondary	Numbers of patients with complications	Assessment according to Clavien-Dindo grading	30 days postoperative