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Prevention of Surgical Site Infections
This study is currently recruiting participants.
Study NCT00353613   Information provided by The University of Texas Health Science Center, Houston
First Received: July 17, 2006   Last Updated: November 3, 2009   History of Changes

July 17, 2006
November 3, 2009
March 2007
June 2010   (final data collection date for primary outcome measure)
Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections
Complete list of historical versions of study NCT00353613 on ClinicalTrials.gov Archive Site
Surgical site infections [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Surgical site infections
 
Prevention of Surgical Site Infections
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.

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.

 
Interventional
Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Surgical Wound Infection
Behavioral: Package of targeted interventions to reduce error
  • Other: LBJ Hospital
  • Other: Ben Taub Hospital
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
900
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact: Lillian S Kao, MD 713-566-5095 Lillian.S.Kao@uth.tmc.edu
Contact: Kevin P Lally, MD 713-500-7300 Kevin.P.Lally@uth.tmc.edu
United States
 
NCT00353613
Lillian S. Kao, MD, Associate Professor, UT Health Science Center at Houston
HSC-MS-050570, RWJ ID#57405
The University of Texas Health Science Center, Houston
Robert Wood Johnson Foundation
Principal Investigator: Lillian S Kao, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP