Prevention of Surgical Site Infections

Not Applicable

Completed

• Conditions: Surgical Wound Infection
• Interventions: Behavioral: Package of targeted interventions to reduce error

• Registration Number: NCT00353613
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Study Timeline

• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-18
• Study Start: 2007-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Package of targeted interventions to reduce error	LBJ Hospital
2	Package of targeted interventions to reduce error	Ben Taub Hospital

Primary Outcome Measures

Name	Time	Method
Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections	1 year

Secondary Outcome Measures

Name	Time	Method
Surgical site infections	1 year

Trial Locations

Locations (2)

Lyndon Baines Johnson General Hospital; 🇺🇸 Houston, Texas, United States

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States