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Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00953784
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : June 30, 2010
Information provided by:
Dallas VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Surgical Wound Infections Colorectal Surgery Procedure: standard operating management Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
Study Start Date : April 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

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
Procedure: standard operating management
As previously described
Other Name: Extended management

Primary Outcome Measures :
  1. %/type Surgical wound infections rated per infection classifications of NNIS/CDC [ Time Frame: with in 30 days post-op ]

Secondary Outcome Measures :
  1. %/type surgical wound infections per classifications per NNIS/CDC [ Time Frame: at hospital discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00953784

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United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
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Study Chair: James LePage, Ph.D ACOS for Research VANorth Tx Health Care System
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Thomas Anthony, MD Chief of Surgery, VANTXHCS Dallas, TX Identifier: NCT00953784    
Other Study ID Numbers: 07-025
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: June 30, 2010
Last Verified: May 2010
Keywords provided by Dallas VA Medical Center:
wound infections
Additional relevant MeSH terms:
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Communicable Diseases
Surgical Wound Infection
Wound Infection
Surgical Wound
Postoperative Complications
Pathologic Processes
Wounds and Injuries