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Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00953784
Enrollment
197
Registered
2009-08-06
Start date
2007-04-30
Completion date
2010-02-28
Last updated
2010-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery, Surgical Wound Infections

Keywords

surgery, wound infections, colorectal

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

Interventions

PROCEDUREstandard operating management

As previously described

Sponsors

Dallas VA Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
%/type Surgical wound infections rated per infection classifications of NNIS/CDCwith in 30 days post-op

Secondary

MeasureTime frame
%/type surgical wound infections per classifications per NNIS/CDCat hospital discharge

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026