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NCT Number: NCT04503642

Changing the Surgical Team for Wound Closure and Surgical Site Infection

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.

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Key information

Conditions

Incidence of Surgical Site Infection Fascial Hernia Infections Morality Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Visceral and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Changing the surgical team for wound closure

Procedure

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.

Primary outcomes

  1. Number of patients with SSIs

    Time frame: 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 outcomes

  1. Postoperative Mortality at 30 days

    Time frame: 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.

  2. Numbers of patients with fascial dehiscence at 30 days postoperative

    Time frame: 30 days postoperative

  3. Numbers of patients with complications

    Time frame: 30 days postoperative

    Assessment according to Clavien-Dindo grading

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 7, 2020
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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