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Clinical Trials/NCT00353613
NCT00353613
Completed
Not Applicable

Prevention of Surgical Site Infections

The University of Texas Health Science Center, Houston2 sites in 1 country900 target enrollmentMarch 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgical Wound Infection
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
900
Locations
2
Primary Endpoint
Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections
Status
Completed
Last Updated
12 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
December 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lillian Kao

Associate Professor - Surgery

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • All patients undergoing laparotomy at either Ben Taub Hospital or Lyndon Baines Johnson Hospital in Houston, Texas

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections

Time Frame: 1 year

Secondary Outcomes

  • Surgical site infections(1 year)

Study Sites (2)

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