Multicenter Infection Surveillance Study Following Colorectal Procedures (MISS)

Halyard Health

Status: Completed

Conditions: Surgical Wound Infection

Treatments: Device: ON-Q Silver soaker System; Drug: Patient controlled analgesia

Study type: Observational

Funder types: Industry

Identifiers

NCT00762060

MISScolorectal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

289 participants in 2 patient groups

Active

Description:

Surgical site continuous local anesthetic infusion with ONQ silver Soaker System

Treatment:

Device: ON-Q Silver soaker System

Control

Description:

Hospital standard of care for pain management (Patient controlled analgesia or epidural)

Treatment:

Drug: Patient controlled analgesia