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Prevention of Surgical Site Infections

Primary Purpose

Surgical Wound Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Package of targeted interventions to reduce error
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound Infection focused on measuring Antibiotic prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients undergoing laparotomy at either Ben Taub Hospital or Lyndon Baines Johnson Hospital in Houston, Texas Exclusion Criteria: None

Sites / Locations

  • Lyndon Baines Johnson General Hospital
  • Ben Taub General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

LBJ Hospital

Ben Taub Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Surgical site infections

Full Information

First Posted
July 17, 2006
Last Updated
June 17, 2013
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00353613
Brief Title
Prevention of Surgical Site Infections
Official Title
Prevention of Surgical Site Infections
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Robert Wood Johnson Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Antibiotic prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
LBJ Hospital
Arm Title
2
Arm Type
Other
Arm Description
Ben Taub Hospital
Intervention Type
Behavioral
Intervention Name(s)
Package of targeted interventions to reduce error
Intervention Description
Interventions will include changes in administration of antibiotics and the improved monitoring of blood glucose and body temperature peri-operatively.
Primary Outcome Measure Information:
Title
Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Surgical site infections
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients undergoing laparotomy at either Ben Taub Hospital or Lyndon Baines Johnson Hospital in Houston, Texas Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lillian S Kao, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon Baines Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Prevention of Surgical Site Infections

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