Prevention of Surgical Site Infections

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Behavioral: Package of targeted interventions to reduce error

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 Type: Interventional
• Enrollment (Actual): 900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital
    • Houston, Texas, United States, 77026
      • Lyndon Baines Johnson General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; LBJ Hospital	Behavioral: 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.
Other: 2; Ben Taub Hospital	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgical site infections	1 year

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Lillian S Kao, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 17, 2006
• First Submitted That Met QC Criteria: July 17, 2006
• First Posted (Estimate): July 18, 2006

Study Record Updates

• Last Update Posted (Estimate): June 18, 2013
• Last Update Submitted That Met QC Criteria: June 17, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Antibiotic prophylaxis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Disease Attributes; Infections; Communicable Diseases; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: HSC-MS-050570; RWJ ID#57405