Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

Not Applicable

Completed

• Conditions: Surgical Wound Infections; Colorectal Surgery
• Interventions: Procedure: standard operating management

• Registration Number: NCT00953784
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2009-08-05
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-05
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	standard operating management	Extended management: with no bowel prep except enema,restricted fluids, increased O2,body warming and use of skin protectors during surgery as previously described

Primary Outcome Measures

Name	Time	Method
%/type Surgical wound infections rated per infection classifications of NNIS/CDC	with in 30 days post-op

Secondary Outcome Measures

Name	Time	Method
%/type surgical wound infections per classifications per NNIS/CDC	at hospital discharge

Trial Locations

Locations (1)

VA North Texas Health Care System; 🇺🇸 Dallas, Texas, United States