Multicenter Infection Surveillance Study Following Colorectal Procedures (MISS)

March 17, 2015 updated by: Halyard Health

Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Surgical patients Colorectal procedures

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Active
Surgical site continuous local anesthetic infusion with ONQ silver Soaker System
Device: ON-Q Silver soaker System
Continuous infusion of local anesthetic to surgical site
Other Names:
  • Continuous surgical site local anesthetic infusion
Control
Hospital standard of care for pain management (Patient controlled analgesia or epidural)
Drug: Patient controlled analgesia
IV opioids delivered via PCA
Other Names:
  • PCA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Surgical site infection
Time Frame: 30 days postoperative
30 days postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital length of stay
Time Frame: Average 1 week
Average 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halyard Health

Investigators

  • Principal Investigator: Jay Singh, MD, Piedmont Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 29, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISScolorectal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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