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OpenTrials
Completed

NCT Number: NCT00353613

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ben Taub General Hospital, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Package of targeted interventions to reduce error

Behavioral

Interventions will include changes in administration of antibiotics and the improved monitoring of blood glucose and body temperature peri-operatively.

Primary outcomes

  1. Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections

    Time frame: 1 year

Secondary outcomes

  1. Surgical site infections

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2006
Registry last updated
Jun 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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