Instrumented Spinal FusionNCT02615379
Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion
A study testing EPIFLO in people with Instrumented Spinal Fusion, run by Neogenix, LLC dba Ogenix at 1 site in United States.
Trial summary
EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Instrumented Spinal Fusion
- What is being tested?
- EPIFLO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 31 Mar 2019
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective spinal fusion - posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions
- Patient Age 18-80
- Patients must be considered high risk for infection, meeting one or more of the following criteria:
- Anticipated Surgical duration ≥ 3 hours
- Diabetes Mellitus type I or II
- Anesthesiology ASA score of 3 or above
Show all 11Show fewer
- BMI ≥35
- Patients with malnutrition as indicated by Pre-albumin value of <20
- Chronic corticosteroid use
- Smokers
- Patients on immune modulators
Who cannot join
- Major Study Exclusion Criteria include:
- Pregnancy
- Active infection at the time of surgery
- Persons with decubitus or diabetic ulcers
- Patients undergoing >5 level fusion (Level is defined as crossing a disk space; e.g.,an L3-5 fusion is a 2 level fusion)
- Disseminated Cancer Patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Neurological Surgery Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: A Prospective, Randomized, Parallel Pilot Study of Transdermal, Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion
EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).
Read the detailed description
Surgical site infections (SSI) after instrumented spinal fusions are not rare, and patients with SSI after instrumented spinal surgery often require repeat operations and prolonged intravenous antibiotic therapy. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) has recently become a novel strategy to facilitate wound healing.
The study doctor will give an EPIFLO® unit along with standard wound care to some subjects in this study to see if it is safe and can help them. Another purpose of this study is to find out if using EPIFLO® is better than getting only standard wound care for Surgical site infections (SSI). The sponsor also wants to compare the cost of using the study device and standard wound care to the cost of standard wound care alone. The U.S. Food and Drug Administration (FDA) has approved EPIFLO® to treat skin ulcers (including diabetic skin ulcers), bedsores, amputations, skin grafts, burns, and frostbite.
- Conditions
- Instrumented Spinal Fusion
- Being tested
- EPIFLO
- Keywords
- instrumented spinal fusion, infection, topical oxygen
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPIFLODevice
Also called TCOT, Transdermal Continuous Oxygen Therapy
Transdermal continuous oxygen therapy is oxygen delivery to the wound site directly. Ogenix makes a small portable oxygen concentrator (Trade Name: EPIFLO) that makes continuous transdermal delivery of oxygen possible. It is a 3 ounce oxygen generator that continuously delivers 3 ml of pure oxygen to the wound site.
| Study group | Role | What they receive |
|---|---|---|
| Transdermal Continuous Oxygen Therapy | Experimental | EPIFLO® working study unit, all day, every day for 2 weeks + standard wound care Receives: Device: EPIFLO |
| Standard of care | No intervention | standard wound care for 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection
The primary objective of this study is to assess surgical site infection within 3 months of surgery for "high risk" patients undergoing posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control. Surgical site infection will be clinically assessed by the PI according to CDC criteria. Independent blinded assessment by a clinician blinded to the allocation arm will also be obtained. The number of patients with infection (and the severity of infection) in the treated arm will be compared to the number in the control arm.
Measured: 3 months
Secondary outcomes (2)
Resource utilization
Resource utilization- the sum total of cost of treatments, hospital stays, bandages, nursing care and anything else related to treatment all measured in dollar amounts and then summed
Measured: 3 months
Severity of infection
Severity of infection - Superficial or deep as per CDC classification as assessed by investigator
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start1 Jul 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Mar 2019 (estimated)
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Instrumented Spinal FusionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neogenix, LLC dba Ogenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nestor Tomycz, M.D., Principal investigator, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615379
- Sponsor's protocol ID
- EPF-515
- Status last verified
- Aug 2017
- First submitted
- 18 Nov 2015
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel Pilot Study of Transdermal, Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Instrumented Fusion
- ClinicalTrials.gov ID
- NCT02615379
- Acronym / sponsor ID
- EPF-515
- Conditions
- Instrumented Spinal Fusion
- Keywords
- instrumented spinal fusion, infection, topical oxygen
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administrative reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neogenix, LLC dba OgenixIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 26 Nov 2015 (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.
EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).
Detailed description
Surgical site infections (SSI) after instrumented spinal fusions are not rare, and patients with SSI after instrumented spinal surgery often require repeat operations and prolonged intravenous antibiotic therapy. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) has recently become a novel strategy to facilitate wound healing.
The study doctor will give an EPIFLO® unit along with standard wound care to some subjects in this study to see if it is safe and can help them. Another purpose of this study is to find out if using EPIFLO® is better than getting only standard wound care for Surgical site infections (SSI). The sponsor also wants to compare the cost of using the study device and standard wound care to the cost of standard wound care alone. The U.S. Food and Drug Administration (FDA) has approved EPIFLO® to treat skin ulcers (including diabetic skin ulcers), bedsores, amputations, skin grafts, burns, and frostbite.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdermal Continuous Oxygen Therapy | Experimental | Device: EPIFLOEPIFLO® working study unit, all day, every day for 2 weeks + standard wound care |
| Standard of care | No intervention | –standard wound care for 2 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Elective spinal fusion - posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions
- Patient Age 18-80
- Patients must be considered high risk for infection, meeting one or more of the following criteria:
Key exclusion criteria (6 listed)
- Pregnancy
- Active infection at the time of surgery
- Persons with decubitus or diabetic ulcers
- Patients undergoing >5 level fusion (Level is defined as crossing a disk space; e.g.,an L3-5 fusion is a 2 level fusion)
- Disseminated Cancer Patients
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 |
|---|---|---|
| EPIFLOAlso: TCOT, Transdermal Continuous Oxygen TherapyTransdermal continuous oxygen therapy is oxygen delivery to the wound site directly. Ogenix makes a small portable oxygen concentrator (Trade Name: EPIFLO) that makes continuous transdermal delivery of oxygen possible. It is a 3 ounce oxygen generator that continuously delivers 3 ml of pure oxygen to the wound site. | Device | Transdermal Continuous Oxygen Therapy |
Primary outcome
Incidence of surgical site infection
Time frame: 3 months
The primary objective of this study is to assess surgical site infection within 3 months of surgery for "high risk" patients undergoing posterior cervical, posterior thoracic, or posterior lumbar instrumented spinal fusions in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control. Surgical site infection will be clinically assessed by the PI according to CDC criteria. Independent blinded assessment by a clinician blinded to the allocation arm will also be obtained. The number of patients with infection (and the severity of infection) in the treated arm will be compared to the number in the control arm.
2 secondary outcomes
Resource utilization
Time frame: 3 months
Severity of infection
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Instrumented Spinal Fusion
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
RecruitingObservational study
Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions
Spinal Fusion
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.
Nestor Tomycz, M.D. principal investigator
Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPIFLO in people with Instrumented Spinal Fusion, run by Neogenix, LLC dba Ogenix 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 11 inclusion and 6 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: withdrawn, as of the sponsor's last update on 14 Aug 2017. 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. 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 was withdrawn before enrolling participants, so there are no results.
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 surgical site infection (time frame: 3 months). 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 14 Aug 2017.