Surgical Wound InfectionsPOWINCT00915967

Prevention of Neurosurgical Wound Infections

A study testing Vancomycin in people with Surgical Wound Infections, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Surgical Wound Infections
What is being tested?: Vancomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 214 participants
Where: 1 siteUnited States
Study dates: 13 May 2009to 19 Dec 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

deep brain stimulators (DBS)
spinal cord stimulators (SCS)
motor cortex stimulators (MCS)
vagus nerve stimulators (VNS)
peripheral nerve stimulators (PNS)

Who cannot join

allergies to vancomycin
immunocompromise or taking immunosuppressant drugs
currently taking aminoglycoside antibiotics, such as amikacin, gentamicin, neomycin, streptomycin or tobramycin
diagnosed renal failure
currently undergoing chemotherapy
pregnancy
non-english speakers
unable to return for follow-up, or unable to be contacted by telephone

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospital, Oregon Health & Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Pilot Project: Prevention of Neurosurgical Wound Infections

The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.

Conditions: Surgical Wound Infections
Being tested: Vancomycin, Placebo (Saline Solution)
Keywords: Infection, Vancomycin, Neurosurgery, Stimulator, Pump, Deep Brain Stimulation, Intrathecal Pump
Medical subject headings: Surgical Wound Infection, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VancomycinDrug
Subjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure.
Placebo (Saline Solution)Drug
Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.

Study groups in NCT00915967
Study group	Role	What they receive
Vancomycin	Experimental	Subjects in the experimental group will receive Vancomycin injected directly into the wound pocket. Receives: Drug: Vancomycin
Saline	Placebo comparator	Subjects in the saline group will receive a Saline injection directly into the wound pocket. Receives: Drug: Placebo (Saline Solution)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Infection That Requires Removal of the Neurosurgical Device
The primary outcome was infection that required removal of the implanted device within 6 months of surgery. At our institution all patients with evidence of hardware infection have the entire stimulation/pump system removed. Subjects were either seen in clinic or reached by telephone more than 6 months after surgery and assessed for whether they had had infection requiring hardware removal or any superficial infection requiring additional post-operative antibiotics.
Measured: Six months post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 200919 Dec 2014

First posted8 Jun 2009 (estimated)
Study start13 May 2009
Primary completion19 Dec 2014
Study completion19 Dec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Surgical Wound InfectionsStudies of the same condition, open and under way.
More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 214 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00915967
Sponsor's protocol ID: IRB_5170
Acronym: POWI
Status last verified: Jan 2019
First submitted: 5 Jun 2009
Last updated: 30 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Miller JP, Acar F, Burchiel KJ. Significant reduction in stereotactic and functional neurosurgical hardware infection after local neomycin/polymyxin application. J Neurosurg. 2009 Feb;110(2):247-50. doi: 10.3171/2008.6.17605.
PubMed 19263587

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgical Wound Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Project: Prevention of Neurosurgical Wound Infections
ClinicalTrials.gov ID: NCT00915967
Acronym / sponsor ID: POWI / IRB_5170
Conditions: Surgical Wound Infections
Keywords: Infection, Vancomycin, Neurosurgery, Stimulator, Pump, Deep Brain Stimulation, Intrathecal Pump
Study type: Interventional
Recruitment status: Completed
Enrolment: 214 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Study start: 13 May 2009 (actual)
Primary completion: 19 Dec 2014 (actual)
Study completion: 19 Dec 2014 (actual)
First posted: 8 Jun 2009 (estimated)
Results: Posted 30 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this study is to determine whether injecting the antibiotic vancomycin directly into surgical wounds can decrease the rate of infection following implantation of neurosurgical devices.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Vancomycin	Experimental	Drug: VancomycinSubjects in the experimental group will receive Vancomycin injected directly into the wound pocket.
Saline	Placebo comparator	Drug: Placebo (Saline Solution)Subjects in the saline group will receive a Saline injection directly into the wound pocket.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

deep brain stimulators (DBS)
spinal cord stimulators (SCS)
motor cortex stimulators (MCS)
vagus nerve stimulators (VNS)
peripheral nerve stimulators (PNS)

Key exclusion criteria (8 listed)

allergies to vancomycin
immunocompromise or taking immunosuppressant drugs
currently taking aminoglycoside antibiotics, such as amikacin, gentamicin, neomycin, streptomycin or tobramycin
diagnosed renal failure
currently undergoing chemotherapy

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
VancomycinSubjects randomized to the vancomycin group will receive an injection (up to 10 mL) of 5 mg/mL vancomycin administered directly into the wound with a blunt needle following watertight fascial closure.	Drug	Vancomycin
Placebo (Saline Solution)Subjects randomized to the saline group will receive an injection (up to 10 mL) of saline solution directly into the wound following watertight fascial closure.	Drug	Saline

Primary outcome

Incidence of Infection That Requires Removal of the Neurosurgical Device
Time frame: Six months post-operation
The primary outcome was infection that required removal of the implanted device within 6 months of surgery. At our institution all patients with evidence of hardware infection have the entire stimulation/pump system removed. Subjects were either seen in clinic or reached by telephone more than 6 months after surgery and assessed for whether they had had infection requiring hardware removal or any superficial infection requiring additional post-operative antibiotics.

Results and safety

Results posted to the registry on 30 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vancomycin	98	97
Saline	100	98

Primary outcome: Incidence of Infection That Requires Removal of the Neurosurgical Device

Time frame: Six months post-operation. Count of participants. Unit: Participants

Measure	Vancomycin n = 98	Saline n = 100
Value	97	98

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vancomycin	0 of 98 (0%)	2 of 98 (2%)	0 of 98
Saline	0 of 100 (0%)	5 of 100 (5%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19263587Miller JP, Acar F, Burchiel KJ. Significant reduction in stereotactic and functional neurosurgical hardware infection after local neomycin/polymyxin application. J Neurosurg. 2009 Feb;110(2):247-50. doi: 10.3171/2008.6.17605.

Related trials for Surgical Wound Infections

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)

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.

Kim J Burchiel, MD principal investigator

Department of Neurological Surgery, Oregon Health & Science University

Valerie C Anderson, PhD, MCR principal investigator

Department of Neurological Surgery, Oregon Health & Science University

Stephen T Magill, PhD principal investigator

School of Medicine, Oregon Health & Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vancomycin in people with Surgical Wound Infections, run by Oregon Health and Science University at 1 site in United States.

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 5 inclusion and 8 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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 30 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incidence of Infection That Requires Removal of the Neurosurgical Device (time frame: Six months post-operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00915967, which also lists 1 linked publication.

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 30 Apr 2019.