Anorectal SurgeriesPhase 2NCT02617706
Transdermal Continuous Oxygen Therapy for Infection Prophylaxis in High- Risk Patients Undergoing Colon Surgery
A Phase 2 study testing Epiflo in people with Anorectal Surgeries, 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
- Anorectal Surgeries
- 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
- Jan 2017to Jan 2019
- 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 colo-rectal surgery with or without anastomosis and with or without stoma
- Patient age: 18-80
Who cannot join
- Pregnancy
- Anesthesiology ASA score of 4 or above
- fever or existing signs of infection at the time of surgery
- Diabetes Mellitus type I or II with HbA1C level 12% or more
- Persons with decubitus or diabetic ulcers
- Subjects with peritoneal metastases
- Patients with severe malnutrition as indicated by Prealbumin value of <20
- BMI ≥50
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of General Surgery Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: A Prospective, Randomized, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Standard of Care to Assess Postoperative Wound Infection Rate in Colon and Rectal Resections
EPIFLO® unit along with standard wound care vs only standard wound care for Surgical site infections (SSI).
Read the detailed description
Anorectal procedures more often lead to surgical site infections. Such infections are unfortunately frequent and can be difficult for the patient and the treating physician. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) is intended to promote the healing process in chronic wounds as an adjunct to standard wound care in wound management and treatment
- Conditions
- Anorectal Surgeries
- Being tested
- Epiflo
- Keywords
- Anorectal surgeries, 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 - 4 weeks + standard wound care Receives: Device: Epiflo |
| Standard of care | No intervention | standard wound care for 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with surgical site infections measured with the Southampton Scoring System. The number of subjects with infection of the surgical site will be compared using chi-square or Fisher Exact test.
The primary objective of this study is to assess surgical site infection within 30 days of surgery for "high risk" patients undergoing colo-rectal surgery in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control Measures as either yes infection or no infection
Measured: 30 days
Secondary outcomes (3)
Severity of infection measured with the Southampton Scoring System
Severity of infection using Southampton Scoring System. To maintain the trial-wise Type I error rate at 0.05, a closed test procedure will be used for the secondary endpoints
Measured: 30 days
Number of days until patients surgical site is healed
Time to heal. To maintain the trial-wise Type I error rate at 0.05, a closed test procedure will be used for the secondary endpoints
Measured: 30 days
Resource utilization - cost of treatments, hospital stays, bandages, nursing care
Resource utilization - cost of treatments, hospital stays, bandages, nursing care all measured in dollar amounts and then summed
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 posted1 Dec 2015 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: financial reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal SurgeriesStudies 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
- Investigators
- Sarang Sarangapani, Ph.D., Study director, Neogenix,LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617706
- Sponsor's protocol ID
- EPF-615
- Status last verified
- Oct 2016
- First submitted
- 18 Nov 2015
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 Study Comparing Transdermal, Continuous Oxygen Delivery to Standard of Care to Assess Postoperative Wound Infection Rate in Colon and Rectal Resections
- ClinicalTrials.gov ID
- NCT02617706
- Acronym / sponsor ID
- EPF-615
- Conditions
- Anorectal Surgeries
- Keywords
- Anorectal surgeries, infection, topical oxygen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: financial reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neogenix, LLC dba OgenixIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 1 Dec 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
Anorectal procedures more often lead to surgical site infections. Such infections are unfortunately frequent and can be difficult for the patient and the treating physician. Wound hypoxia has been identified as a pathogenic mechanism behind wound infection and poor healing. Transdermal oxygen delivery (EPIFLO) is intended to promote the healing process in chronic wounds as an adjunct to standard wound care in wound management and treatment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdermal Continuous Oxygen Therapy | Experimental | Device: EpifloEPIFLO® working study unit, all day, every day for 2 - 4 weeks + standard wound care |
| Standard of care | No intervention | –standard wound care for 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective colo-rectal surgery with or without anastomosis and with or without stoma
- Patient age: 18-80
Key exclusion criteria (8 listed)
- Pregnancy
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
Number of patients with surgical site infections measured with the Southampton Scoring System. The number of subjects with infection of the surgical site will be compared using chi-square or Fisher Exact test.
Time frame: 30 days
The primary objective of this study is to assess surgical site infection within 30 days of surgery for "high risk" patients undergoing colo-rectal surgery in patients receiving adjunct Transdermal Continuous Oxygen therapy vs. standard of care control Measures as either yes infection or no infection
3 secondary outcomes
Severity of infection measured with the Southampton Scoring System
Time frame: 30 days
Number of days until patients surgical site is healed
Time frame: 30 days
Resource utilization - cost of treatments, hospital stays, bandages, nursing care
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 14 Aug 2017.
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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.
Sarang Sarangapani, Ph.D. study director
Neogenix,LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epiflo in people with Anorectal Surgeries, 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 2 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: 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.
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 patients with surgical site infections measured with the Southampton Scoring System. The number of subjects with infection of the surgical site will be compared using chi-square or Fisher Exact test. (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 14 Aug 2017.