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Multicenter Infection Surveillance Study Following Colorectal Procedures (MISS)

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ClinicalTrials.gov Identifier: NCT00762060
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : March 19, 2015
Sponsor:
Information provided by (Responsible Party):
Halyard Health

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.

Condition or disease Intervention/treatment
Surgical Wound Infection Device: ON-Q Silver soaker System Drug: Patient controlled analgesia

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
Actual Enrollment : 289 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures
Study Start Date : November 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : September 2007

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 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




Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 30 days postoperative ]

Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: Average 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762060


Sponsors and Collaborators
Halyard Health
Investigators
Principal Investigator: Jay Singh, MD Piedmont Medical Center

Responsible Party: Halyard Health
ClinicalTrials.gov Identifier: NCT00762060     History of Changes
Other Study ID Numbers: MISScolorectal
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: December 2014

Keywords provided by Halyard Health:
colorectal surgery

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wound Infection
Surgical Wound
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