Incidence of Surgical Site InfectionNCT04503642
Changing the Surgical Team for Wound Closure and Surgical Site Infection
An observational study of Incidence of Surgical Site Infection and Morality, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incidence of Surgical Site Infection, Morality, Fascial Hernia
- What is being tested?
- Changing the surgical team for wound closure
- Type of treatment
- Surgery or procedure
- How many people
- 1,160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2018to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Department of Visceral Surgery of the University Hospital Bern, a tertiary care centre
Who may be able to join
- 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
Who cannot join
- Patients < 18 years of age
- Patients with preexisting SSI
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Visceral and transplant surgery, Berne University Hospital
Bern, 3010
About this study
Official title: 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.
- Being tested
- Changing the surgical team for wound closure
- Keywords
- Surgical Site Infection, Changing the surgical team
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing the surgical team for wound closureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Changing the surgical team for wound closure | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days postoperative
Secondary outcomes (3)
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.
Measured: 30 days postoperative
Numbers of patients with fascial dehiscence at 30 days postoperative
Measured: 30 days postoperative
Numbers of patients with complications
Assessment according to Clavien-Dindo grading
Measured: 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Mar 2018
- Primary completion30 Nov 2018
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incidence of Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Beldi, MD, Principal investigator, Visceral and transplant sugery, university hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503642
- Sponsor's protocol ID
- CLOT-T trial
- Status last verified
- Nov 2024
- First submitted
- 3 Aug 2020
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33151978
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Changing the Surgical Team for Wound Closure on Surgical Site Infection: a Matched Case-control Study
- ClinicalTrials.gov ID
- NCT04503642
- Acronym / sponsor ID
- CLOT-T trial
- Keywords
- Surgical Site Infection, Changing the surgical team
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,160 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Procedure: Changing the surgical team for wound closureThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Department of Visceral Surgery of the University Hospital Bern, a tertiary care centre
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients < 18 years of age
- Patients with preexisting SSI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changing the surgical team for wound closureThe 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. | Procedure or surgery | Intervention Group |
Primary outcome
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
3 secondary outcomes
Postoperative Mortality at 30 days
Time frame: 30 days postoperative
Numbers of patients with fascial dehiscence at 30 days postoperative
Time frame: 30 days postoperative
Numbers of patients with complications
Time frame: 30 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Derived from this study: PubMed 33151978Salm 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.
Related trials for Incidence of Surgical Site Infection
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Enrolling by invitation
A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital
Surgical Site Infection (SSI)
Active, not recruitingObservational study
Bacteria and Intestinal Translocation in Surgery (Bandit)
Surgical Site Infection
Not yet recruiting
Effects of Intensive Glycemic Control in the Postoperative Period of Neurosurgical Patients on the Incidence of Surgical Site Infection
Surgical Site Infection (SSI)
Not yet recruitingObservational study
Incidence of Ssi After c.s
Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Beldi, MD principal investigator
Visceral and transplant sugery, university hospital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incidence of Surgical Site Infection and Morality, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with SSIs (time frame: 30 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04503642, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.