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OpenTrials
Completed

NCT Number: NCT00953784

Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

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.

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Key information

Conditions

Surgical Wound Infections Colorectal Surgery Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA North Texas Health Care System

Dallas, Texas, 75216, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard operating management

Procedure

As previously described

Other names: Extended management

Primary outcomes

  1. %/type Surgical wound infections rated per infection classifications of NNIS/CDC

    Time frame: with in 30 days post-op

Secondary outcomes

  1. %/type surgical wound infections per classifications per NNIS/CDC

    Time frame: at hospital discharge

Sponsors and collaborators

Lead sponsor

Dallas VA Medical Center

Fed

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 6, 2009
Registry last updated
Jun 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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