Multicenter Infection Surveillance Study Following Colorectal Procedures (MISS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halyard Health
ClinicalTrials.gov Identifier:
NCT00762060
First received: September 29, 2008
Last updated: March 17, 2015
Last verified: December 2014
  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: ON-Q Silver soaker System
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 Halyard Health:

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

Secondary Outcome Measures:
  • Hospital length of stay [ Time Frame: Average 1 week ] [ 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 System
Device: ON-Q Silver soaker System
Continuous infusion of local anesthetic to surgical site
Other Name: 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 Name: PCA

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Halyard Health
Investigators
Principal Investigator: Jay Singh, MD Piedmont Medical Center
  More Information

Responsible Party: Halyard Health
ClinicalTrials.gov Identifier: NCT00762060     History of Changes
Other Study ID Numbers: MISScolorectal 
Study First Received: September 29, 2008
Last Updated: March 17, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Halyard Health:
colorectal surgery

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

ClinicalTrials.gov processed this record on July 28, 2016