Prevention of Surgical Site Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

LBJ Hospital

Group Type OTHER

Package of targeted interventions to reduce error

Intervention Type BEHAVIORAL

Interventions will include changes in administration of antibiotics and the improved monitoring of blood glucose and body temperature peri-operatively.

2

Ben Taub Hospital

Group Type OTHER

Package of targeted interventions to reduce error

Intervention Type BEHAVIORAL

Interventions will include changes in administration of antibiotics and the improved monitoring of blood glucose and body temperature peri-operatively.

Interventions

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Package of targeted interventions to reduce error

Interventions will include changes in administration of antibiotics and the improved monitoring of blood glucose and body temperature peri-operatively.

Intervention Type BEHAVIORAL