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OpenTrials
Completed

NCT Number: NCT00762060

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.

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Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ON-Q Silver soaker System

Device

Continuous infusion of local anesthetic to surgical site

Other names: Continuous surgical site local anesthetic infusion

patient controlled analgesia

Drug

IV opioids delivered via PCA

Other names: PCA

Primary outcomes

  1. Surgical site infection

    Time frame: 30 days postoperative

Secondary outcomes

  1. Hospital length of stay

    Time frame: Average 1 week

Sponsors and collaborators

Lead sponsor

Halyard Health

Industry

Registry information

Official study title

Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures

Acronym: MISS

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 30, 2008
Registry last updated
Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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