- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00953784
Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
June 29, 2010 updated by: Dallas VA Medical Center
This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A comparison between standard operating room:
- use of pre-op bowel prep (Golytely or Phosphosoda,plus 3 doses of oral antibiotics(Erythromycin and Neomycin), and fleets enema the day before surgery
- Standard anesthesia FiO2 (approx. 30-50%)during surgery
- Standard IV fluids during surgery(greater than 200cc per hour)
- Standard post-op O2 by mask for 2 hours
To extended operating room procedures of:
- No po antibiotics or pre-op bowel prep other than enema prior to surgery
- Skin warming at least 15 minutes prior to and during surgery(core temp 36C+)
- IOBAN drapes and Plastic wound protectors used during surgery
- Restricted IV fluids less than 200cc per hour during surgery
- Increased FiO2 to 80% during surgery and 2 hours after by mask
Monitoring for post-op wound infections at discharge and up to 30days post-op
Study Type
Interventional
Enrollment (Actual)
197
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75216
- VA North Texas Health Care System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Scheduled VA adult elective colorectal surgery patient
Exclusion Criteria:
- Non VA adults, emergent colorectal surgery, scheduled multiple surgery procedures,pts with other infections being treated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
Standard management
|
|
Active Comparator: 2
Extended management: with no bowel prep except enema,restricted fluids, increased O2,body warming and use of skin protectors during surgery as previously described
|
As previously described
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
%/type Surgical wound infections rated per infection classifications of NNIS/CDC
Time Frame: with in 30 days post-op
|
with in 30 days post-op
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
%/type surgical wound infections per classifications per NNIS/CDC
Time Frame: at hospital discharge
|
at hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: James LePage, Ph.D, ACOS for Research VANorth Tx Health Care System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
August 5, 2009
First Submitted That Met QC Criteria
August 5, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Estimate)
June 30, 2010
Last Update Submitted That Met QC Criteria
June 29, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-025 (CHRMS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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