ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevention of Surgical Site Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00353613
Recruitment Status : Completed
First Posted : July 18, 2006
Last Update Posted : June 18, 2013
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Lillian Kao, The University of Texas Health Science Center, Houston

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.

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Behavioral: Package of targeted interventions to reduce error Not Applicable

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  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Surgical Site Infections
Study Start Date : March 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Surgical site infections [ Time Frame: 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 18, 2006    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

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

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