Changing the Surgical Team for Wound Closure and Surgical Site Infection

Completed

• Conditions: Incidence of Surgical Site Infection; Fascial Hernia; Morality
• Interventions: Procedure: Changing the surgical team for wound closure

• Registration Number: NCT04503642
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-11-30
• Study Completion: 2019-02-28
• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention Group	Changing the surgical team for wound closure	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.

Primary Outcome Measures

Name	Time	Method
Number of patients with SSIs	30 days postoperative	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

Secondary Outcome Measures

Name	Time	Method
Postoperative Mortality at 30 days	30 days postoperative	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.
Numbers of patients with fascial dehiscence at 30 days postoperative	30 days postoperative
Numbers of patients with complications	30 days postoperative	Assessment according to Clavien-Dindo grading

Trial Locations

Locations (1)

Dep. of Visceral and transplant surgery, Berne University Hospital; 🇨🇭 Berne, Switzerland