Surgical Site InfectionBanditNCT03554148
Bacteria and Intestinal Translocation in Surgery (Bandit)
An observational study of Surgical Site Infection, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. Preoperatively baseline health data is collected and a skin swab and rectal swab for baseline skin and gut microbiota is taken. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- How many people
- 209 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2017to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Consecutive patients undergoing elective visceral surgery. Mostly for oncological indications.
Who may be able to join
- Informed Consent
- All Ages
- All Gender
- Elective Abdominal Surgery
- Age > 18
- All approached (laparoscopic, open)
- All ethnic and sociodemographic backgrounds
- Sufficient knowledge of the study language (German)
Who cannot join
- pregnant or lactating women
- no operation performed (i.e. only planned)
- insufficient knowledge of project language (German)
- lack of informed consent
- known colonization with multi-resistant bacteria (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or extended spectrum betalactamase (ESBL))
- known cirrhotic liver disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Inselspital, University Hospital Bern, Visceral Surgery Department
Bern, 3008
About this study
Official title: Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.
Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. Preoperatively baseline health data is collected and a skin swab and rectal swab for baseline skin and gut microbiota is taken. During the surgery additional clinical data and additional samples will be obtained. Additional samples include: rectal swab, biopsies of the resected specimen (lymph node, peritoneum, intestinal content, mucosa), venous blood sample (7.5ml) at the end of the operation, liver biopsy and skin biopsy. Postoperative health data is recorded. If a surgical site infection occurs a swab is taken too. With 16 sRNA (small ribonucleic acid) based sequencing the investigators will quantify the abundance of the different bacterial species in all samples. Primary outcome will be to assess a difference of 16sRNA signal in the liver and lymph node biopsies between patients with and patients without surgical site infection. Secondary outcomes include variables predicting the occurence of surgical site infections and a model describing the way bacteria may take to cause wound infection.
- Conditions
- Surgical Site Infection
- Being tested
- No intervention
- 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.
No interventionOther
This is purely an observational study. Groups SSI/No SSI are defined by the occurence of a surgical site infection.
| Study group | Role | What they receive |
|---|---|---|
| SSI | This group receives an additional swab of the surgical site infection. Follow up is terminated at the occurence of SSI. Receives: Other: No intervention | |
| No SSI | This group is systematically followed up until 30 days after surgery (one year if a implant is implanted, e.g. mesh) by a third party (www.swissnoso.ch). Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of bacterial DNA in liver biopsy
Rationale: One of the aims is to test how the liver acts as primary barrier for blood-borne bacteria during the operation.
Sampling: During elective abdominal surgery a biopsy with the Tru-Cut™ Needle (Baxter healthcare Co., 16G Chicago, USA) is performed as recommended by the manufacturer. Hemostasis is achieved by Application of mono-polar Electrocautery.
Processing: The sample is immediately snap-frozen in liquid nitrogen. Storage: Biobank: -80°C. Analysis: Polymerase chain reaction (PCR) with bacteria specific primers, Sequencing of the PCR product (IonTorrent) to determine the present microbiota (species if possible, at least families). The difference in positive/negative liver probes is compared for patients with and without surgical site infections (Chi squared Test).
Measured: day 0 (operation day)
Secondary outcomes (4)
Detection of bacterial DNA in mesenteric lymph node
Rationale: To address the interstitial translocation and drainage of microbes during colonic surgery. Positive lymph nodes are a surrogate marker of SSI. However, positive lymph nodes may just be a surrogate a marker of a high amount of bacteria being translocated from intestinal lumen to the interstitial space during surgery. Or, mesenteric lymph nodes truly are a significant line of defence against surgical site infections.
Sampling: A lymph node is sampled from the resected specimen within the OR under sterile conditions. The lymph node is excised. Half of this lymph node is sampled for research purposes, the other half is marked with a suture and sent for pathological evaluation with the rest of the specimen.
Processing: Sample is immediately snap-frozen in liquid nitrogen. Storage: Biobank: -80°C. Analysis: same as liver biopsy. The difference in positive/negative lymph node probes is compared for patients with and without surgical site infections (Chi squared Test).
Measured: day 0 (operation day)
Number of patients with surgical site infection (SSI)
The number of patients with surgical site infection are recoded. Surgical site infection is defined according to the Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017.
Measured: outpatient visit, usually around 7 to 21 days before operation
Modelling bacterial travel behaviour in multimodal networks
Rationale: The way bacteria travel from places they grow in abundance(gut,skin), ending up in a surgical site to cause infection, has not been studied.
Sampling: In addition to the preoperative skin and rectal swab and the intraoperative liver and lymph node biopsy, additional samples are collected in a prospective manner: biopsy of the visceral peritoneum, parietal peritoneum, intestinal mucosa and skin. Swab of intestinal content. Venous blood. All samples are handled sterile and are immediately frozen in liquid nitrogen and stored at -80°C.
Analysis: For the surgical site infections subgroup, samples are analyzed as described above(bacteria specific PCR followed by Sequencing). The sequencing results translate tinto abundance of families/species. Multimodal networks are applied to describe the potential travel behaviour of bacteria.
Measured: day 0
Baseline skin and gut microbiota
The baseline gut and skin microbiota are metagenomically characterized on the basis of 16S rRNA genomic DNA sequencing.
Statistical analysis: Differences of skin and gut microbiota between patients with and without surgical site infections are compared using PerMANOVA. The correlation between distinct microbiota (families or clusters) and the occurence surgical site infections is tested using multiple logistic regressions.
Measured: outpatient visit, usually around 7 to 21 days before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Jul 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guido Beldi, MD, Prof, Study director, Inselspital, University Hospital of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554148
- Sponsor's protocol ID
- Bandit
- Acronym
- Bandit
- Status last verified
- Apr 2026
- First submitted
- 9 Nov 2017
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bacterial Translocation on the Incidence of Surgical Site Infection in Abdominal Surgery: Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT03554148
- Acronym / sponsor ID
- Bandit / Bandit
- Conditions
- Surgical Site Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2018 (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.
Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. Preoperatively baseline health data is collected and a skin swab and rectal swab for baseline skin and gut microbiota is taken. During the surgery additional clinical data and additional samples will be obtained. Additional samples include: rectal swab, biopsies of the resected specimen (lymph node, peritoneum, intestinal content, mucosa), venous blood sample (7.5ml) at the end of the operation, liver biopsy and skin biopsy. Postoperative health data is recorded. If a surgical site infection occurs a swab is taken too. With 16 sRNA (small ribonucleic acid) based sequencing the investigators will quantify the abundance of the different bacterial species in all samples. Primary outcome will be to assess a difference of 16sRNA signal in the liver and lymph node biopsies between patients with and patients without surgical site infection. Secondary outcomes include variables predicting the occurence of surgical site infections and a model describing the way bacteria may take to cause wound infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSI | – | Other: No interventionThis group receives an additional swab of the surgical site infection. Follow up is terminated at the occurence of SSI. |
| No SSI | – | Other: No interventionThis group is systematically followed up until 30 days after surgery (one year if a implant is implanted, e.g. mesh) by a third party (www.swissnoso.ch). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing elective visceral surgery. Mostly for oncological indications.
Key inclusion criteria (8 listed)
- Informed Consent
- All Ages
- All Gender
- Elective Abdominal Surgery
- Age > 18
Key exclusion criteria (6 listed)
- pregnant or lactating women
- no operation performed (i.e. only planned)
- insufficient knowledge of project language (German)
- lack of informed consent
- known colonization with multi-resistant bacteria (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or extended spectrum betalactamase (ESBL))
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 |
|---|---|---|
| No interventionThis is purely an observational study. Groups SSI/No SSI are defined by the occurence of a surgical site infection. | Other | No SSI, SSI |
Primary outcome
Detection of bacterial DNA in liver biopsy
Time frame: day 0 (operation day)
Rationale: One of the aims is to test how the liver acts as primary barrier for blood-borne bacteria during the operation. Sampling: During elective abdominal surgery a biopsy with the Tru-Cut™ Needle (Baxter healthcare Co., 16G Chicago, USA) is performed as recommended by the manufacturer. Hemostasis is achieved by Application of mono-polar Electrocautery. Processing: The sample is immediately snap-frozen in liquid nitrogen. Storage: Biobank: -80°C. Analysis: Polymerase chain reaction (PCR) with bacteria specific primers, Sequencing of the PCR product (IonTorrent) to determine the present microbiota (species if possible, at least families). The difference in positive/negative liver probes is compared for patients with and without surgical site infections (Chi squared Test).
4 secondary outcomes
Detection of bacterial DNA in mesenteric lymph node
Time frame: day 0 (operation day)
Number of patients with surgical site infection (SSI)
Time frame: outpatient visit, usually around 7 to 21 days before operation
Modelling bacterial travel behaviour in multimodal networks
Time frame: day 0
Baseline skin and gut microbiota
Time frame: outpatient visit, usually around 7 to 21 days before operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Surgical Site Infection
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
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, Prof study director
Inselspital, University Hospital of Bern
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 Surgical Site Infection, 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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Detection of bacterial DNA in liver biopsy (time frame: day 0 (operation day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.