NCT00953784

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

June 30, 2010

Status Verified

May 1, 2010

Enrollment Period

2.8 years

First QC Date

August 5, 2009

Last Update Submit

June 29, 2010

Conditions

Surgical Wound InfectionsColorectal Surgery

Keywords

surgerywound infectionscolorectal

Outcome Measures

Primary Outcomes (1)

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

    with in 30 days post-op

Secondary Outcomes (1)

  • %/type surgical wound infections per classifications per NNIS/CDC

    at hospital discharge

Study Arms (2)

1

NO INTERVENTION

Standard management

2

ACTIVE COMPARATOR

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

Interventions

standard operating managementPROCEDURE

As previously described

Also known as: Extended management
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled VA adult elective colorectal surgery patient

You may not qualify if:

  • Non VA adults, emergent colorectal surgery, scheduled multiple surgery procedures,pts with other infections being treated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Related Publications (1)

  • Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S. Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011 Mar;146(3):263-9. doi: 10.1001/archsurg.2010.249. Epub 2010 Nov 15.

    PMID: 21079110DERIVED

Related Links

MeSH Terms

Conditions

Surgical Wound InfectionWound Infection

Condition Hierarchy (Ancestors)

InfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • James LePage, Ph.D

    ACOS for Research VANorth Tx Health Care System

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

April 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

June 30, 2010

Record last verified: 2010-05

Locations

US(1)