Multicenter Infection Surveillance Study Following Colorectal Procedures

N/ACompletedNCT00762060

Halyard Health289 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

289

Conditions

Surgical Wound Infection

Interventions

ON-Q Silver soaker SystemDEVICE

Continuous infusion of local anesthetic to surgical site

Patient controlled analgesiaDRUG

IV opioids delivered via PCA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Surgical site infection

Time frame: 30 days postoperative

Secondary Outcomes

Hospital length of stay

Time frame: Average 1 week

Data from ClinicalTrials.gov

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