Post-operative infection Surgical site infection Pneumonia Sepsis
Conditions
Interventions
Sponsors
Radboud university medical center
Eligibility
Inclusion criteria
Inclusion criteria: Willing and able to provide written informed consent. No acute infection at the time of vaccination or surgery (defined as fever above 38.5 ¢XC). Patients scheduled for: Colon surgery, sigmoid surgery, or rectal surgery via an open laparotomy. Liver and gall bladder surgery via an open laparotomy. Pancreas surgery (Whipple procedures) via an open laparotomy. Uterus/ovaria extirpations, tumour debulking surgery via an open laparotomy. Nefrectomy/urinary bladder surgery via an open laparotomy. Vascular surgery (aortic) via an open laparotomy.
Exclusion criteria
Exclusion criteria: Immunosuppressed status, due to medication or otherwise. Corticosteroid or other immunosuppressive treatment, including general radiation. Inhaled steroids are not a contra-indication. Malignant condition such as lymphoma, leukaemia or other tumour of the reticulo-endothelial system that is not in remission. HIV infection Auto-inflammatory or auto-immune 㻠diseases. Pregnancy or lactation. Any serious or active medical or psychiatric illness which would interfere with treatment, assessment, or compliance. History of TBC infection or positive Mantoux test, contact with TBC patients or born in a TBC endemic country. Vaccination within 3 months prior to inclusion (subjects cannot be vaccinated with other vaccines during the study). Previous BCG vaccination or known allergy or hypersensitivity to BCG vaccine. History of serious atherosclerotic disease (unstable Angina Pectoris, history of ischemic CVA). History of diabetes mellitus type 2 with metformin as anti-diabetic medication. Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study outcome is the assessment of immune cell function after BCG vaccination and after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the occurrence of SSI, pneumonia, sepsis, UTI, ileus | — |
Contacts
Public ContactL.S. Helder
Outcome results
None listed