Multicenter Infection Surveillance Study Following Colorectal Procedures

NCT ID: NCT00762060

Last Updated: 2015-03-19

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

Total Enrollment

289 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-09-30

Brief Summary

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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

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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 procedures.

Conditions

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Surgical Wound Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Active

Surgical site continuous local anesthetic infusion with ONQ silver Soaker System

ON-Q Silver soaker System

Intervention Type DEVICE

Continuous infusion of local anesthetic to surgical site

Control

Hospital standard of care for pain management (Patient controlled analgesia or epidural)

Patient controlled analgesia

Intervention Type DRUG

IV opioids delivered via PCA

Interventions

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ON-Q Silver soaker System

Continuous infusion of local anesthetic to surgical site

Intervention Type DEVICE

Patient controlled analgesia

IV opioids delivered via PCA

Intervention Type DRUG

Other Intervention Names

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Continuous surgical site local anesthetic infusion PCA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Halyard Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jay Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Medical Center

Other Identifiers

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MISScolorectal

Identifier Type: -

Identifier Source: org_study_id

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