Multicenter Infection Surveillance Study Following Colorectal Procedures

Completed

• Conditions: Surgical Wound Infection
• Interventions: Device: ON-Q Silver soaker System; Drug: Patient controlled analgesia

• Registration Number: NCT00762060
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-11
• Primary Completion: 2007-08
• Study Completion: 2007-09
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Status Verified: 2014-12
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active	ON-Q Silver soaker System	Surgical site continuous local anesthetic infusion with ONQ silver Soaker System
Control	Patient controlled analgesia	Hospital standard of care for pain management (Patient controlled analgesia or epidural)

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days postoperative

Secondary Outcome Measures

Name	Time	Method
Hospital length of stay	Average 1 week