Surgical Wound InfectionMISSNCT00762060
Multicenter Infection Surveillance Study Following Colorectal Procedures
An observational study of Surgical Wound Infection, run by Halyard Health.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- ON-Q Silver soaker System
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 289 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Surgical patients Colorectal procedures
Who may be able to join
- Men and women, >18 years of age;
- Scheduled for elective colon procedure;
- Ability to complete patient survey questionnaires;
- Provision of informed consent
Who cannot join
- 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
About this study
Official title: Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures
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.
Read the 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.
- Conditions
- Surgical Wound Infection
- Being tested
- ON-Q Silver soaker System, Patient controlled analgesia
- Keywords
- colorectal surgery
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ON-Q Silver soaker SystemDevice
Also called Continuous surgical site local anesthetic infusion
Continuous infusion of local anesthetic to surgical site
Patient controlled analgesiaDrug
Also called PCA
IV opioids delivered via PCA
| Study group | Role | What they receive |
|---|---|---|
| Active | Surgical site continuous local anesthetic infusion with ONQ silver Soaker System Receives: Device: ON-Q Silver soaker System | |
| Control | Hospital standard of care for pain management (Patient controlled analgesia or epidural) Receives: Drug: Patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Measured: 30 days postoperative
Secondary outcomes (1)
Hospital length of stay
Measured: Average 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startNov 2006
- Primary completionAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halyard Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jay Singh, MD, Principal investigator, Piedmont Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762060
- Sponsor's protocol ID
- MISScolorectal
- Acronym
- MISS
- Status last verified
- Dec 2014
- First submitted
- 29 Sep 2008
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Multicenter Infection Surveillance Study Following Colorectal Procedures
- ClinicalTrials.gov ID
- NCT00762060
- Acronym / sponsor ID
- MISS / MISScolorectal
- Conditions
- Surgical Wound Infection
- Keywords
- colorectal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Halyard HealthIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | – | Device: ON-Q Silver soaker SystemSurgical site continuous local anesthetic infusion with ONQ silver Soaker System |
| Control | – | Drug: Patient controlled analgesiaHospital standard of care for pain management (Patient controlled analgesia or epidural) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Surgical patients Colorectal procedures
Key inclusion criteria (4 listed)
- Men and women, >18 years of age;
- Scheduled for elective colon procedure;
- Ability to complete patient survey questionnaires;
- Provision of informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ON-Q Silver soaker SystemAlso: Continuous surgical site local anesthetic infusionContinuous infusion of local anesthetic to surgical site | Device | Active |
| Patient controlled analgesiaAlso: PCAIV opioids delivered via PCA | Drug | Control |
Primary outcome
Surgical site infection
Time frame: 30 days postoperative
1 secondary outcome
Hospital length of stay
Time frame: Average 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Singh, MD principal investigator
Piedmont Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound Infection, run by Halyard Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 30 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.