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Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

NCT ID: NCT00953784

Last Updated: 2010-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-02-28

Brief Summary

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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

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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

Conditions

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Surgical Wound Infections Colorectal Surgery

Keywords

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surgery wound infections colorectal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Standard management

Group Type NO_INTERVENTION

No interventions assigned to this group

2

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

Group Type ACTIVE_COMPARATOR

standard operating management

Intervention Type PROCEDURE

As previously described

Interventions

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standard operating management

As previously described

Intervention Type PROCEDURE

Other Intervention Names

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Extended management

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dallas VA Medical Center

FED

Sponsor Role lead

Responsible Party

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VANTXHCS Dallas, TX

Principal Investigators

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James LePage, Ph.D

Role: STUDY_CHAIR

ACOS for Research VANorth Tx Health Care System

Locations

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VA North Texas Health Care System

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21079110 (View on PubMed)

Related Links

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http://www.northtexas.va.gov/

homepage

Other Identifiers

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07-025

Identifier Type: -

Identifier Source: org_study_id