Back to resultsMinimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
Primary Purpose
Surgical Wound Infections, Colorectal Surgery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard operating management
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infections focused on measuring surgery, wound infections, colorectal
Eligibility Criteria
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
Sites / Locations
- VA North Texas Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
1
2
Arm Description
Standard management
Extended management: with no bowel prep except enema,restricted fluids, increased O2,body warming and use of skin protectors during surgery as previously described
Outcomes
Primary Outcome Measures
%/type Surgical wound infections rated per infection classifications of NNIS/CDC
Secondary Outcome Measures
%/type surgical wound infections per classifications per NNIS/CDC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00953784
Brief Title
Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
Official Title
Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dallas VA Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infections, Colorectal Surgery
Keywords
surgery, wound infections, colorectal
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Standard management
Arm Title
2
Arm Type
Active Comparator
Arm Description
Extended management: with no bowel prep except enema,restricted fluids, increased O2,body warming and use of skin protectors during surgery as previously described
Intervention Type
Procedure
Intervention Name(s)
standard operating management
Other Intervention Name(s)
Extended management
Intervention Description
As previously described
Primary Outcome Measure Information:
Title
%/type Surgical wound infections rated per infection classifications of NNIS/CDC
Time Frame
with in 30 days post-op
Secondary Outcome Measure Information:
Title
%/type surgical wound infections per classifications per NNIS/CDC
Time Frame
at hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James LePage, Ph.D
Organizational Affiliation
ACOS for Research VANorth Tx Health Care System
Official's Role
Study Chair
Facility Information:
Facility Name
VA North Texas Health Care System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21079110
Citation
Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S. Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011 Mar;146(3):263-9. doi: 10.1001/archsurg.2010.249. Epub 2010 Nov 15.
Results Reference
derived
Links:
URL
http://www.northtexas.va.gov/
Description
homepage
Learn more about this trial
Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
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