The Effect of an Enhanced PerOperative Care and Health Protection Programme on Surgical Site Infections (SSI) after elective abdominal surgery

Phase 4

Completed

• Conditions: Surgical site infection; Surgical wound infection; 10004018

• Registration Number: NL-OMON50566
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1433

Inclusion Criteria

Adult patients undergoing elective abdominal surgery resulting in an incision
larger than 5 cm

Exclusion Criteria

Emergency surgery, reoperations because of complicated surgery within 90 days
and two staged surgical procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence rate of SSI at 30 days follow-up, evaluated from the Dutch National<br /><br>Surgical Complication Registry (LHCR), a complication registry that has been<br /><br>implemented for over fifteen years now in Dutch Hospitals.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints: SSI rate evaluated at 3 months follow-up, WHO disability<br /><br>assessment schedule 2.0, (in)direct medical and non-medical costs, quality<br /><br>adjusted life years (QALY) , anastomotic leakage rate, incisional hernia rate,<br /><br>Serious adverse events (SAE) and mortality. Parallel assessment of incidence<br /><br>rate of SSI, by the CDC definition, by medical chart reviews to correct<br /><br>possible registration effect.<br /><br><br /><br>Additional secondary outcomes for participants in the AMC: Local tissue<br /><br>oxygenation from admission to the surgical unit until discharge from recovery<br /><br>back to the ward, immunologic effects defined by neutrophil intracellular ROS<br /><br>generation, phagocytosis assays, plasma cytokine concentrations, HLA-DRA mRNA<br /><br>expression, malondialdehyde concentration, blood gas parameters, and ex vivo<br /><br>whole blood stimulation.</p><br>