Prevention of Surgical Site Infections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prevention of Surgical Site Infections

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Behavioral: Package of targeted interventions to reduce error


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing laparotomy at either Ben Taub Hospital or Lyndon Baines Johnson Hospital in Houston, Texas Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>LBJ Hospital | Behavioral: Package of targeted interventions to reduce error<br>* Interventions will include changes in administration of antibiotics and the improved monitoring of blood glucose and body temperature peri-operatively.<br>|
| Other: 2<br>Ben Taub Hospital | Behavioral: Package of targeted interventions to reduce error<br>* Interventions will include changes in administration of antibiotics and the improved monitoring of blood glucose and body temperature peri-operatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infections |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic prophylaxis