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| 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 |
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: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | Prevention of Surgical Site Infections |
| 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.
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|
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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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, 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 | 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 | |
| Principal Investigator: | Lillian S Kao, MD | The University of Texas Health Science Center, Houston |
More Information
| Responsible Party: | UT Health Science Center at Houston ( Lillian S. Kao, MD, Associate Professor ) |
| Study ID Numbers: | HSC-MS-050570, RWJ ID#57405 |
| Study First Received: | July 17, 2006 |
| Last Updated: | May 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00353613 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antibiotic prophylaxis |
|
Anti-Bacterial Agents Postoperative Complications Wounds and Injuries |
Disorders of Environmental Origin Surgical Wound Infection Wound Infection |
|
Communicable Diseases Pathologic Processes Postoperative Complications Wounds and Injuries |
Disorders of Environmental Origin Surgical Wound Infection Infection Wound Infection |
