NCT00762060

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
Last Updated

March 19, 2015

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

September 29, 2008

Last Update Submit

March 17, 2015

Conditions

Surgical Wound Infection

Keywords

colorectal surgery

Outcome Measures

Primary Outcomes (1)

  • Surgical site infection

    30 days postoperative

Secondary Outcomes (1)

  • Hospital length of stay

    Average 1 week

Study Arms (2)

Active

Surgical site continuous local anesthetic infusion with ONQ silver Soaker System

Device: ON-Q Silver soaker System

Control

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

Drug: Patient controlled analgesia

Interventions

ON-Q Silver soaker SystemDEVICE

Continuous infusion of local anesthetic to surgical site

Also known as: Continuous surgical site local anesthetic infusion
Active
Patient controlled analgesiaDRUG

IV opioids delivered via PCA

Also known as: PCA
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Surgical patients Colorectal procedures

You may qualify if:

  • Men and women, \>18 years of age;
  • Scheduled for elective colon procedure;
  • Ability to complete patient survey questionnaires;
  • Provision of informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Analgesia, Patient-ControlledPassive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and AnalgesiaSkin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Study Officials

  • Jay Singh, MD

    Piedmont Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2008

First Posted

September 30, 2008

Study Start

November 1, 2006

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

March 19, 2015

Record last verified: 2014-12