Multicenter Infection Surveillance Study Following Colorectal Procedures

Surgical Wound Infection Clinical Trial

— MISS  

Official title:

Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762060
• Other study ID #: MISScolorectal
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: March 17, 2015
• Start date: November 2006
• Est. completion date: September 2007

Study information

• Verified date: December 2014
• Source: Halyard Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: September 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• ON-Q Silver soaker System
Continuous infusion of local anesthetic to surgical site

Drug:
• Patient controlled analgesia
IV opioids delivered via PCA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Halyard Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection		30 days postoperative	Yes
Secondary	Hospital length of stay		Average 1 week	No