Wounds and InjuriesNCT02357628
Effect of Regulated Oxygen-Enriched Negative Pressure Therapy (RO-NPT) On Soft Tissue Wound Repair
An observational study of Wounds and Injuries, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The investigators believe that regulated oxygen-enriched negative Pressure Therapy (RO-NPT) will be beneficial in the reduction or elimination of anaerobic infection in hard-to-heal soft tissue wounds. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Wound treatment with RO-NPT and Wound Irrigation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Mar 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients presenting at the Hillel Yaffe Medical Center for treatment of hard-to-heal wounds that have been selected for RO-NPT.
Who may be able to join
- Patients with hard-to-heal wounds
Who cannot join
- Everyone else
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Moris Topaz, MD, PhD, 972-4630-4689, mtopazmd@yahoo.com
About this study
The investigators believe that regulated oxygen-enriched negative Pressure Therapy (RO-NPT) will be beneficial in the reduction or elimination of anaerobic infection in hard-to-heal soft tissue wounds.
- Conditions
- Wounds and Injuries
- Being tested
- Wound treatment with RO-NPT, Wound Irrigation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound treatment with RO-NPTDevice
Also called Oxygen-enriched vacuum therapy
Wound IrrigationDevice
| Study group | Role | What they receive |
|---|---|---|
| Research Group I | Wound treatment with RO-NPT 40% Receives: Device: Wound treatment with RO-NPT | |
| Research Group II | Wound treatment with RO-NPT 60% Receives: Device: Wound treatment with RO-NPT | |
| Research Group III | Wound treatment with RO-NPT 40% and irrigation Receives: Device: Wound treatment with RO-NPT; Device: Wound Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Closure
Before treatment and after treatment wound area measurements will indicate percentage of closure
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Moris Topaz, MD, Phd, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357628
- Sponsor's protocol ID
- 0078-14-HYMC
- Status last verified
- Feb 2015
- First submitted
- 3 Feb 2015
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Regulated Oxygen-Enriched Negative Pressure Therapy (RO-NPT) On Soft Tissue Wound Repair
- ClinicalTrials.gov ID
- NCT02357628
- Acronym / sponsor ID
- 0078-14-HYMC
- Conditions
- Wounds and Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 6 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.
The investigators believe that regulated oxygen-enriched negative Pressure Therapy (RO-NPT) will be beneficial in the reduction or elimination of anaerobic infection in hard-to-heal soft tissue wounds.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Research Group I | – | Device: Wound treatment with RO-NPTWound treatment with RO-NPT 40% |
| Research Group II | – | Device: Wound treatment with RO-NPTWound treatment with RO-NPT 60% |
| Research Group III | – | Device: Wound treatment with RO-NPT, Device: Wound IrrigationWound treatment with RO-NPT 40% and irrigation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presenting at the Hillel Yaffe Medical Center for treatment of hard-to-heal wounds that have been selected for RO-NPT.
Key inclusion criteria (1 listed)
- Patients with hard-to-heal wounds
Key exclusion criteria (1 listed)
- Everyone else
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 |
|---|---|---|
| Wound treatment with RO-NPTAlso: Oxygen-enriched vacuum therapy | Device | Research Group I, Research Group II, Research Group III |
| Wound Irrigation | Device | Research Group III |
Primary outcome
Wound Closure
Time frame: One Month
Before treatment and after treatment wound area measurements will indicate percentage of closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 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.
Moris Topaz, MD, Phd principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wounds and Injuries, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Feb 2015. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moris Topaz, MD, PhD (972-4-630-4689, mtopazmd@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Closure (time frame: One Month). 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 6 Feb 2015.