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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04503642
Enrollment
1160
Registered
2020-08-07
Start date
2018-03-01
Completion date
2019-02-28
Last updated
2024-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fascial Hernia, Incidence of Surgical Site Infection, Morality

Keywords

Surgical Site Infection, Changing the surgical team

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.

Interventions

PROCEDUREChanging 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.

Sponsors

Insel Gruppe AG, University Hospital Bern
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with SSIs30 days postoperativeSSI 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

MeasureTime frameDescription
Postoperative Mortality at 30 days30 days postoperativeObserver 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 postoperative30 days postoperative
Numbers of patients with complications30 days postoperativeAssessment according to Clavien-Dindo grading

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026