Multicenter Infection Surveillance Study Following Colore... | NCT00762060

Studies
Multicenter Infection Surveillance Study Following Colorectal Procedures

NCT00762060

Sponsor

Halyard Health

Status

Completed

Last Update Posted

Mar 19, 2015Estimated

Enrollment

289Actual

Phase

Not provided

Conditions

Surgical Wound Infection

Interventions

ON-Q Silver soaker System
Patient controlled analgesia

Countries

Not provided

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

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

Nov 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Sep 29, 2008

First Submission Date that Met QC Criteria

Sep 29, 2008

First Posted Date

Sep 30, 2008Estimated

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

Mar 17, 2015

Last Update Posted Date

Mar 19, 2015Estimated

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 study is a multicenter, open label, observational, postmarketing surveillance study of the ON-Q® Silver SoakerTM in the United States and Canada. This study was developed to investigate specific aspects of infection rates and hospital length of stay following routine use of this device in patients undergoing colorectal surgical procedures.

Detailed Description

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

289Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active		Surgical site continuous local anesthetic infusion with ONQ silver Soaker System	Device: ON-Q Silver soaker System
Control		Hospital standard of care for pain management (Patient controlled analgesia or epidural)	Drug: Patient controlled analgesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ON-Q Silver soaker System	Device	Continuous infusion of local anesthetic to surgical site	Active

Measure	Description	Time Frame
Surgical site infection		30 days postoperative

Measure	Description	Time Frame
Hospital length of stay		Average 1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men and women, >18 years of age;
Scheduled for elective colon procedure;
Ability to complete patient survey questionnaires;
Provision of informed consent

Exclusion Criteria:

Patients with a prior allergic reaction to Morphine, Demerol, Dilaudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);
Procedures for hemorrhoids;
Inability to perform follow up assessments

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

Surgical patients Colorectal procedures

Sampling Method

Probability Sample

Name	Affiliation	Role
Jay Singh, MD	Piedmont Medical Center	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016058	Analgesia, Patient-Controlled
D010323	Passive Cutaneous Anaphylaxis

Ancestor Terms

ID	Term
D000698	Analgesia
D000760	Anesthesia and Analgesia
D012882	Skin Tests
D007159	Immunologic Tests

Browse Leaves

Not provided

Browse Branches

Not provided