Prevention of Surgical Site Infections

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Lillian Kao, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00353613
First received: July 17, 2006
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Surgical Wound Infection
Behavioral: Package of targeted interventions to reduce error

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Surgical Site Infections

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Surgical site infections [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 900
Study Start Date: March 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353613

Locations
United States, Texas
Lyndon Baines Johnson General Hospital
Houston, Texas, United States, 77026
Ben Taub General Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Lillian S Kao, MD The University of Texas Health Science Center, Houston
  More Information

Additional Information:
No publications provided

Responsible Party: Lillian Kao, Associate Professor - Surgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00353613     History of Changes
Other Study ID Numbers: HSC-MS-050570, RWJ ID#57405
Study First Received: July 17, 2006
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Antibiotic prophylaxis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Surgical Wound Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014