Changing the Surgical Team for Wound Closure and Surgical Site Infection

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

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.

Study Overview

• Status: Completed
• Conditions: Morality; Incidence of Surgical Site Infection; Fascial Hernia
• Intervention / Treatment: Procedure: Changing the surgical team for wound closure

• Study Type: Observational
• Enrollment (Actual): 1160

Contacts and Locations

Study Locations

• Switzerland
  • Berne, Switzerland, 3010
    • Dep. of Visceral and transplant surgery, Berne University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Department of Visceral Surgery of the University Hospital Bern, a tertiary care centre

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention Group; The intervention consisted in the closure of the abdominal wall and skin by a second surgical team which included a board-certified surgeon and a resident.	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.
Baseline Group; During the baseline period, closure of the abdominal wall was performed by the main surgical team, the same team that performed the whole surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of patients with fascial dehiscence at 30 days postoperative		30 days postoperative
Numbers of patients with complications	Assessment according to Clavien-Dindo grading	30 days postoperative
Postoperative Mortality at 30 days	Observer receives the information during the follow-up phone call that the patient died. If patients do not respond to follow-up phone calls, five documented attempts to contact the patients followed by rapid contacts with the subject's general practitioner or other medical staff involved in the medical treatment of the patients, will be performed before loss to follow-up is documented. In addition, the Zivilstandsamt will be contacted once 3 months after surgery.	30 days postoperative

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Guido Beldi, MD, Visceral and transplant sugery, university hospital Berne

Publications and helpful links

General Publications

• Salm L, Chapalley D, Perrodin SF, Tschan F, Candinas D, Beldi G. Impact of changing the surgical team for wound closure on surgical site infection: A matched case-control study. PLoS One. 2020 Nov 5;15(11):e0241712. doi: 10.1371/journal.pone.0241712. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Changing the surgical team
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Disease Attributes; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection
• Other Study ID Numbers: CLOT-T trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No