Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

This study has been completed.
Sponsor:
Information provided by:
Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT00953784
First received: August 5, 2009
Last updated: June 29, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention
Surgical Wound Infections
Colorectal Surgery
Procedure: standard operating management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures:
  • %/type Surgical wound infections rated per infection classifications of NNIS/CDC [ Time Frame: with in 30 days post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • %/type surgical wound infections per classifications per NNIS/CDC [ Time Frame: at hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: April 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: standard operating management
As previously described
Other Name: Extended management

Detailed Description:

A comparison between standard operating room:

  1. 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
  2. Standard anesthesia FiO2 (approx. 30-50%)during surgery
  3. Standard IV fluids during surgery(greater than 200cc per hour)
  4. Standard post-op O2 by mask for 2 hours

To extended operating room procedures of:

  1. No po antibiotics or pre-op bowel prep other than enema prior to surgery
  2. Skin warming at least 15 minutes prior to and during surgery(core temp 36C+)
  3. IOBAN drapes and Plastic wound protectors used during surgery
  4. Restricted IV fluids less than 200cc per hour during surgery
  5. 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953784

Locations
United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
Investigators
Study Chair: James LePage, Ph.D ACOS for Research VANorth Tx Health Care System
  More Information

Additional Information:
No publications provided by Dallas VA Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Anthony, MD Chief of Surgery, VANTXHCS Dallas, TX
ClinicalTrials.gov Identifier: NCT00953784     History of Changes
Other Study ID Numbers: 07-025
Study First Received: August 5, 2009
Last Updated: June 29, 2010
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Dallas VA Medical Center:
surgery
wound infections
colorectal

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014