Minimization of Surgical Site Infections for Pts Undergoi... | NCT00953784

Studies
Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery

NCT00953784

Sponsor

Dallas VA Medical Center

Status

Completed

Last Update Posted

Jun 30, 2010Estimated

Enrollment

197Actual

Phase

Not Applicable

Conditions

Surgical Wound Infections
Colorectal Surgery

Interventions

standard operating management

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Aug 5, 2009

First Submission Date that Met QC Criteria

Aug 5, 2009

First Posted Date

Aug 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2010

Last Update Posted Date

Jun 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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
Standard anesthesia FiO2 (approx. 30-50%)during surgery
Standard IV fluids during surgery(greater than 200cc per hour)
Standard post-op O2 by mask for 2 hours

To extended operating room procedures of:

No po antibiotics or pre-op bowel prep other than enema prior to surgery
Skin warming at least 15 minutes prior to and during surgery(core temp 36C+)
IOBAN drapes and Plastic wound protectors used during surgery
Restricted IV fluids less than 200cc per hour during surgery
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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

197Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
standard operating management	Procedure	As previously described	2	Extended management

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
%/type surgical wound infections per classifications per NNIS/CDC		at hospital discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James LePage, Ph.D	ACOS for Research VANorth Tx Health Care System	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA North Texas Health Care System		Dallas	Texas	75216	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21079110	Derived	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.

Type	Date	Date Unknown
Release	Apr 5, 2011
Reset	Apr 28, 2011
Release	May 17, 2011
Reset	Sep 29, 2011

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 5, 2011			Apr 28, 2011
May 17, 2011

ID	Term
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013530	Surgical Wound Infection
D014946	Wound Infection