Prevention of Surgical Site Infections

Status Completed

Clinical Trial Summary

The primary research question is whether interventions to prevent caregiver and system errors will increase the proportion of laparotomy patients who receive recommended measures to prevent surgical site infections.

Clinical Trial Description

Background: Surgical site infections (SSIs) cause significant and largely preventable morbidity, mortality, and resource use due to failure to comply with evidence-based guidelines. Quality improvement programs report increased compliance with these guidelines, but are subject to a variety of biases.

Hypothesis: The primary hypothesis is that a targeted intervention program will increase the proportion of patients in a county hospital who receive recommended interventions to prevent SSIs, when assessed in the most rigorous feasible clinical trial. The specific aims of the trial are to establish practical surveillance measures to determine the percentage of patients whose care complies with 5 major guidelines to prevent SSIs; to use chart review, direct observation, attitude surveys, and focus groups to identify, quantify, and address latent and active errors linked to non-compliance, and to develop, implement, and assess the effectiveness of an intervention program to increase guideline compliance.

Study Design: An innovative trial design will be performed with 3 staggered phases in the two major county hospitals in Houston, TX. This design allows for adjustment for temporal trends and hospital differences in assessing the intervention program in a large, high-risk, disadvantaged urban population. Based on a compliance goal of 95%, this design has adequate power to detect even a small absolute increase ( >= 5%) above baseline in the percentage of patients receiving all 5 recommended preventive measures. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00353613
Study type	Interventional
Source	The University of Texas Health Science Center, Houston
Contact
Status	Completed
Phase	N/A
Start date	March 2007
Completion date	December 2012

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