Prevention of Surgical Site Infections - Full Text View

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

ChemIDplus related topics:

Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

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 ]

Estimated Enrollment:	900
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (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

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

Contacts


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

Locations


United States, Texas
	Lyndon Baines Johnson General Hospital	Recruiting
	Houston, Texas, United States, 77026
	Contact: Lillian S Kao, MD 713-566-5095 Lillian.S.Kao@uth.tmc.edu
	Contact: Debbie F Lew, MPH, CCRC 713-500-6886 Debbie.F.Lew@uth.tmc.edu
	Principal Investigator: Lillian S Kao, MD
	Ben Taub General Hospital	Not yet recruiting
	Houston, Texas, United States, 77030
	Contact: Kathleen R Liscum, MD liscum@bcm.tmc.edu
	Contact: Matthew Carrick, MD mcarrick@bcm.tmc.edu
	Sub-Investigator: Kathleen R Liscum, MD
	Sub-Investigator: Matthew Carrick, MD

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

Robert Wood Johnson Physician Faculty Scholars bio page This link exits the ClinicalTrials.gov site

Responsible Party:	UT Health Science Center at Houston ( Lillian S. Kao, MD, Associate Professor )
Study ID Numbers:	HSC-MS-050570, RWJ ID#57405
First Received:	July 17, 2006
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00353613
Health Authority:	United States: Institutional Review Board

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

Antibiotic prophylaxis

Study placed in the following topic categories:

Postoperative Complications

Wounds and Injuries

Disorders of Environmental Origin

Surgical Wound Infection

Wound Infection

Additional relevant MeSH terms:

Communicable Diseases

Pathologic Processes

Infection

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	The University of Texas Health Science Center, Houston Robert Wood Johnson Foundation
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00353613