Surgical site infection wound infection
Conditions
Interventions
A postoperative basal-bolus insulin regimen (intervention) will be compared to
a sliding scale insulin regimen (control).
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. > 18 years old 2. Diagnosed with type 2 diabetes mellitus 3. Undergoing abdominal or vascular surgery 4. Admitted to one of the participating surgical wards 5. Expected duration of stay at least one overnight stay 6. Willing and able to provide informed consent and complete the questionnaires
Exclusion criteria
Exclusion criteria: 1. Diagnosed with type 1 diabetes mellitus 2. Female who is pregnant or breast-feeding. 3. Undergoing a total pancreatectomy or surgery that leads to total insulin deficiency 4. Undergoing bariatric surgery 5. Patients using a continuous insulin pump at home 6. Patients undergoing a necrotectomy/wound debridement from a pre-existent wound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of surgical site infections (SSI) within 30 days after surgery, defined by the Centers for Disease Control and prevention (CDC) criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other hospital-acquired infections, the length of hospital stay, readmission rates at 30 days after surgery, days at home at 30 days after surgery (DAH30), the time in glucose range (3.9-10 mmol/l), time below glucose range (10 mmol/l) measured with a blinded continuous glucose monitor (CGM) during the stay in the hospital, adherence to the protocol, health-related quality of life 30 days after surgery (EuroQoL 5D5L), postoperative disability scores 30 days after surgery (WHODAS 2.0) and associated costs from a healthcare and societal perspective (costs per prevented SSI and QALY's gained). | — |
Countries
Netherlands
Contacts
Public ContactA.Y. Stobbe
Amsterdam UMC
Outcome results
None listed