Complication of Surgical ProcedurePhase 2NCT02374294
TCOT Effectiveness in Preventing Wound Infections in Perineal Resections
A Phase 2 study testing Epiflo in people with Complication of Surgical Procedure, run by Neogenix, LLC dba Ogenix.
Trial summary
In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the surgical site) has been shown to decrease infection rate. Several pressure wounds in the coccyx have been successfully treated to closure with Transdermal Continuous Oxygen Therapy (TCOT) Given the wound healing properties of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Complication of Surgical Procedure
- 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
- No sites listed yet
- Study dates
- Sep 2015to Sep 2015
- Phase
- Phase 2
- 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 perineal resection,
- Patients having abdominal-perineal resections or perineal resections will be included.
- Patient age: 18-80
Who cannot join
- • expected surgery time of less than one hour,
- fever or existing signs of infection at the time of surgery
About this study
Official title: A Prospective, Randomized, Parallel Study Comparing Transdermal, Continuous Oxygen Therapy (TCOT) to Standard of Care to Assess Postoperative Wound Infection Rate in Perineal Resections
In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the surgical site) has been shown to decrease infection rate. Several pressure wounds in the coccyx have been successfully treated to closure with Transdermal Continuous Oxygen Therapy (TCOT) Given the wound healing properties of TCOT, particularly in infection-prone anatomic locations such as coccyx, and the microbicidal properties of oxygen, it is expected that the infection rate in abdominoperineal (AP) resection surgery can be reduced with transdermal continuous oxygen therapy. The primary objective of this study is to compare the number of surgical site infections associated with perineal surgery within 28 days between subjects randomized to receive EPIFLO or Standard of Care
Read the detailed description
EPIFLO is a Small, silent disposable, battery-operated oxygen concentrator capable of delivering 98% to 100% oxygen (balance moisture) for seven days at a rate of ~3.0 ml/hour; and 60" long sterile cannula (tube) that conveys the oxygen concentrator to the area beneath the bandage overlying the wound.
The primary objective of this study is to compare the number of surgical site infections associated with perineal surgery within 30 days between subjects randomized to receive EPIFLO or Standard of Care. Secondary Study objectives include Resource utilization and duration of hospitalization.
Hypothesis 1: The proportion of surgical site infections will be lower for patients treated with Transdermal Continuous Oxygen Therapy (TCOT) Hypothesis 2: In the patients who develop infections, wounds will be smaller and heal more rapidly in those treated with Transdermal Continuous Oxygen Therapy.
Key Safety Assessments Include potential dermatological toxicity changes attributed to EPIFLO as measured by observed and reported discomfort and changes in skin during and after the Treatment Period (It is essential to establish the difference between toxicity from the dressing vs. toxicity arising out of EPIFLO).
This Study will be a randomized controlled trial of 30 patients aged 18-80 years who are scheduled to undergo elective perineal resection surgery at the University of Maryland Medical Center. This study is designed to be a Phase II safety \& efficacy study. Patients who met the inclusion/exclusion criteria will be randomized to receive the interventional device with Standard of Care or Standard of Care only (1:1). The patients will be equally divided between the two arms. Sham devices are not involved in this study. Wound infections will be diagnosed by the investigator using Centers for Disease Control and Prevention Criteria. As an additional measure to prevent bias, the pictures of the wounds may be sent to an independent clinical specialist for assessment of infection; this specialist will be blinded to get an objective opinion.
The expected time on study is 1 month ( 27-30 days). This does not include screening period which occurs when the subject consents to be in the study (signs the informed consent) to when they have their surgery (day 1). The screening period can be up to 28 days. While in the study, there are four study visits: Visit 1 day 1 is the day of the surgery, and randomization. The second study visit will be the day of the post surgery discharge (day 3-5). The third study visit will be 14 days following surgery, (day 14) and the Final study visit will be the day of the post surgical follow up visit (day 28). The total treatment period may be 14 or 28 days. After 14-days of treatment, if the wound is completely healed, the treatment phase is complete. If the wound is not completely healed they will receive an additional 14 days of treatment. Either way the patient's healing progress will be followed for a total study duration of 30 days.
- Conditions
- Complication of Surgical Procedure
- Being tested
- Epiflo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpifloDevice
EPIFLO: Small, silent disposable, battery-operated oxygen concentrator capable of delivering 98% to 100% oxygen (balance moisture) for seven days at a rate of ~3.0 ml/hour; and 60" long sterile cannula (tube) that conveys the oxygen concentrator to the area beneath the bandage overlying the wound.
| Study group | Role | What they receive |
|---|---|---|
| Epiflo | Experimental | After the surgery, but before the application of dressing to the surgical site the kit containing the investigation device (and four cannula) is opened. The EPIFLO cannula (sterile package) is opened and applied to the surgical site and sealed with the dressings per protocol. The EPIFLO device is connected to the cannula after making sure the switch is in the ON position.The EPIFLO device is mounted on the patient's body in a convenient location using the Pouch and Arm band provided. At Treatment Visit 3 (Postoperative day #14, +/- 1 day) a new device is given and the old one disposed of. Intermittent dressing changes will take place as needed. Receives: Device: Epiflo |
| Standard of Care | No intervention | After the surgery, but before the application of dressing to the surgical site if upon opening, the kit contains only a weighted block, then, the regular wound dressing protocol, standard of care, will be followed. Intermittent dressing changes will take place as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of surgical site infections
number of surgical site infections associated with perineal surgery within 30 days between subjects randomized to receive EPIFLO or Standard of Care.
Measured: 30 days
Secondary outcomes (1)
resource utilization (duration of time in hospital)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: could not come to budget agreement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neogenix, LLC dba Ogenix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374294
- Sponsor's protocol ID
- EPF-614
- Status last verified
- Sep 2015
- First submitted
- 11 Feb 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Parallel Study Comparing Transdermal, Continuous Oxygen Therapy (TCOT) to Standard of Care to Assess Postoperative Wound Infection Rate in Perineal Resections
- ClinicalTrials.gov ID
- NCT02374294
- Acronym / sponsor ID
- EPF-614
- Conditions
- Complication of Surgical Procedure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: could not come to budget agreement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neogenix, LLC dba OgenixIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Feb 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.
In colorectal surgery, oxygen insufflation (which leads to higher oxygen concentration in the surgical site) has been shown to decrease infection rate. Several pressure wounds in the coccyx have been successfully treated to closure with Transdermal Continuous Oxygen Therapy (TCOT) Given the wound healing properties of TCOT, particularly in infection-prone anatomic locations such as coccyx, and the microbicidal properties of oxygen, it is expected that the infection rate in abdominoperineal (AP) resection surgery can be reduced with transdermal continuous oxygen therapy. The primary objective of this study is to compare the number of surgical site infections associated with perineal surgery within 28 days between subjects randomized to receive EPIFLO or Standard of Care
Detailed description
EPIFLO is a Small, silent disposable, battery-operated oxygen concentrator capable of delivering 98% to 100% oxygen (balance moisture) for seven days at a rate of ~3.0 ml/hour; and 60" long sterile cannula (tube) that conveys the oxygen concentrator to the area beneath the bandage overlying the wound.
The primary objective of this study is to compare the number of surgical site infections associated with perineal surgery within 30 days between subjects randomized to receive EPIFLO or Standard of Care. Secondary Study objectives include Resource utilization and duration of hospitalization.
Hypothesis 1: The proportion of surgical site infections will be lower for patients treated with Transdermal Continuous Oxygen Therapy (TCOT) Hypothesis 2: In the patients who develop infections, wounds will be smaller and heal more rapidly in those treated with Transdermal Continuous Oxygen Therapy.
Key Safety Assessments Include potential dermatological toxicity changes attributed to EPIFLO as measured by observed and reported discomfort and changes in skin during and after the Treatment Period (It is essential to establish the difference between toxicity from the dressing vs. toxicity arising out of EPIFLO).
This Study will be a randomized controlled trial of 30 patients aged 18-80 years who are scheduled to undergo elective perineal resection surgery at the University of Maryland Medical Center. This study is designed to be a Phase II safety \& efficacy study. Patients who met the inclusion/exclusion criteria will be randomized to receive the interventional device with Standard of Care or Standard of Care only (1:1). The patients will be equally divided between the two arms. Sham devices are not involved in this study. Wound infections will be diagnosed by the investigator using Centers for Disease Control and Prevention Criteria. As an additional measure to prevent bias, the pictures of the wounds may be sent to an independent clinical specialist for assessment of infection; this specialist will be blinded to get an objective opinion.
The expected time on study is 1 month ( 27-30 days). This does not include screening period which occurs when the subject consents to be in the study (signs the informed consent) to when they have their surgery (day 1). The screening period can be up to 28 days. While in the study, there are four study visits: Visit 1 day 1 is the day of the surgery, and randomization. The second study visit will be the day of the post surgery discharge (day 3-5). The third study visit will be 14 days following surgery, (day 14) and the Final study visit will be the day of the post surgical follow up visit (day 28). The total treatment period may be 14 or 28 days. After 14-days of treatment, if the wound is completely healed, the treatment phase is complete. If the wound is not completely healed they will receive an additional 14 days of treatment. Either way the patient's healing progress will be followed for a total study duration of 30 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epiflo | Experimental | Device: EpifloAfter the surgery, but before the application of dressing to the surgical site the kit containing the investigation device (and four cannula) is opened. The EPIFLO cannula (sterile package) is opened and applied to the surgical site and sealed with the dressings per protocol. The EPIFLO device is connected to the cannula after making sure the switch is in the ON position.The EPIFLO device is mounted on the patient's body in a convenient location using the Pouch and Arm band provided. At Treatment Visit 3 (Postoperative day #14, +/- 1 day) a new device is given and the old one disposed of. Intermittent dressing changes will take place as needed. |
| Standard of Care | No intervention | –After the surgery, but before the application of dressing to the surgical site if upon opening, the kit contains only a weighted block, then, the regular wound dressing protocol, standard of care, will be followed. Intermittent dressing changes will take place as needed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective perineal resection,
- Patients having abdominal-perineal resections or perineal resections will be included.
- Patient age: 18-80
Key exclusion criteria (2 listed)
- • expected surgery time of less than one hour,
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 |
|---|---|---|
| EpifloEPIFLO: Small, silent disposable, battery-operated oxygen concentrator capable of delivering 98% to 100% oxygen (balance moisture) for seven days at a rate of ~3.0 ml/hour; and 60" long sterile cannula (tube) that conveys the oxygen concentrator to the area beneath the bandage overlying the wound. | Device | Epiflo |
Primary outcome
number of surgical site infections
Time frame: 30 days
number of surgical site infections associated with perineal surgery within 30 days between subjects randomized to receive EPIFLO or Standard of Care.
1 secondary outcome
resource utilization (duration of time in hospital)
Time frame: 30 days
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 30 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epiflo in people with Complication of Surgical Procedure, run by Neogenix, LLC dba Ogenix.
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 3 inclusion and 2 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 30 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
number of surgical site infections (time frame: 30 days). 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 30 Sep 2015.