Ireland
--:--IST
Recruiting Not applicable

Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.

NCT06638567 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Abraham Hulst, MD, PhD
Phase
Not applicable
Started
2025-01-03
Last updated
2025-01-30

Condition(s) studied

Diabetes Mellitus, Type 2Surgical Site Infection

Investigational drug(s) / intervention(s)

Basal bolus insulin regimen

Basal bolus insulin regimen: Combination of long-acting and short-acting insulin in a proactive schedule for achieving better blood glucose values postoperatively

Study summary

A multicentre, matched-pair, cluster randomised controlled superiority trial to investigate the effect of a proactive basal bolus insulin regimen compared to the reactive sliding scale insulin regimen, targeting a glucose level of 3.9-10.0 mmol/L, to reduce the number of surgical site infections within the first 30 days postoperatively in adult patients with diabetes mellitus type 2.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged 18 or older * Diagnosed with type 2 diabetes mellitus * Undergoing gastointestinal or vascular surgery * Admitted to one of the participating surgical wards * Expected duration of stay at least one overnight stay * Willing and able to provide informed consent Exclusion Criteria: * Diagnosed with type 1 diabetes mellitus * Female of child-bearing potential who is pregnant or breastfeeding. * Undergoing complete pancreatectomy * Undergoing bariatric surgery * Patients using a continuous insulin pump at home * Patients undergoing a necrotectomy/wound debridement from a pre-existent wound.

Primary outcome measure(s)

  • Surgical site infection — Until 30 days after surgery
    Incidence of postoperative surgical site infection, according to the criteria of the centres of disease control (CDC) for superficial incisional SSI, deep incisional SSI and organ / space SSI. SSIs will be measured at 30 days postoperatively via BLUEBELLE questionnaire, diagnosis by surgeon during standard postoperative visit at the surgery clinic 3-5 weeks after surgery and chart review.

Trial sites (1)

FacilityCityRegionStatus
Amsterdam UMC Amsterdam Netherlands Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06638567 on ClinicalTrials.gov ↗ ← All trials in the Netherlands