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| Tracking Information | |||||||||
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| First Received Date ICMJE | July 17, 2006 | ||||||||
| Last Updated Date | November 3, 2009 | ||||||||
| Start Date ICMJE | March 2007 | ||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections | ||||||||
| Change History | Complete list of historical versions of study NCT00353613 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Surgical site infections [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Surgical site infections | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Prevention of Surgical Site Infections | ||||||||
| Official Title ICMJE | Prevention of Surgical Site Infections | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Surgical Wound Infection | ||||||||
| Intervention ICMJE | Behavioral: Package of targeted interventions to reduce error | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 900 | ||||||||
| Estimated Completion Date | June 2010 | ||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00353613 | ||||||||
| Responsible Party | Lillian S. Kao, MD, Associate Professor, UT Health Science Center at Houston | ||||||||
| Study ID Numbers ICMJE | HSC-MS-050570, RWJ ID#57405 | ||||||||
| Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||||||
| Collaborators ICMJE | Robert Wood Johnson Foundation | ||||||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center, Houston | ||||||||
| Verification Date | November 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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