Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

Colorectal Surgery Clinical Trial

Official title:

Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953784
• Other study ID #: 07-025
• Status: Completed
• Phase: N/A
• First received: August 5, 2009
• Last updated: June 29, 2010
• Start date: April 2007
• Est. completion date: February 2010

Study information

• Verified date: May 2010
• Source: Dallas VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery
• Communicable Diseases
• Infection
• Surgical Wound
• Surgical Wound Infection
• Surgical Wound Infections
• Wound Infection

Intervention

Procedure:
• standard operating management
As previously described

Locations

Country	Name	City	State
United States	VA North Texas Health Care System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dallas VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%/type Surgical wound infections rated per infection classifications of NNIS/CDC		with in 30 days post-op
Secondary	%/type surgical wound infections per classifications per NNIS/CDC		at hospital discharge

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