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Prevention of Surgical Site Infections

Prevention of Surgical Site Infections

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00353613
Enrollment
900
Registered
2006-07-18
Start date
2007-03-31
Completion date
2012-12-31
Last updated
2013-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Wound Infection

Keywords

Antibiotic prophylaxis

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.

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.

Interventions

BEHAVIORALPackage 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.

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
The University of Texas Health Science Center, Houston
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Proportion of laparotomy patients receiving recommended measures to prevent surgical site infections1 year

Secondary

MeasureTime frame
Surgical site infections1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026