NCT00353613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

5.8 years

First QC Date

July 17, 2006

Last Update Submit

June 17, 2013

Conditions

Surgical Wound Infection

Keywords

Antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (1)

  • Surgical site infections

    1 year

Study Arms (2)

1

OTHER

LBJ Hospital

Behavioral: Package of targeted interventions to reduce error

2

OTHER

Ben Taub Hospital

Behavioral: Package of targeted interventions to reduce error

Interventions

Package of targeted interventions to reduce errorBEHAVIORAL

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

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lillian S Kao, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - Surgery

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

March 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

US(2)