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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Communicable Diseases
Infection
Surgical Wound Infection
Wound Infection
Pathologic Processes
Postoperative Complications
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014