Multicenter Infection Surveillance Study Following Colorectal Procedures (MISS)

This study has been completed.
Sponsor:
Information provided by:
I-Flow
ClinicalTrials.gov Identifier:
NCT00762060
First received: September 29, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Surgical Wound Infection
Device: Continuous surgical site local anesthetic infusion
Drug: Patient controlled analgesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures

Further study details as provided by I-Flow:

Primary Outcome Measures:
  • Surgical site infection [ Time Frame: 30 days postoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospital length of stay [ Designated as safety issue: No ]

Enrollment: 289
Study Start Date: November 2006
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Active
Surgical site continuous local anesthetic infusion with ONQ silver Soaker
Device: Continuous surgical site local anesthetic infusion
Continuous infusion of local anesthetic to surgical site
Other Name: ON-Q Silver soaker System
Control
Hospital standard of care for pain management (Patient controlled analgesia or epidural)
Drug: Patient controlled analgesia
IV opioids delivered via PCA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Surgical patients Colorectal procedures

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762060

Sponsors and Collaborators
I-Flow
Investigators
Principal Investigator: Jay Singh, MD Piedmont Medical Center
  More Information

No publications provided

Responsible Party: Alan Dine, I-Flow Corporation
ClinicalTrials.gov Identifier: NCT00762060     History of Changes
Other Study ID Numbers: MISScolorectal
Study First Received: September 29, 2008
Last Updated: September 29, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by I-Flow:
colorectal surgery

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014