Negative-Pressure Wound TherapyNCT01603901
Regulated Negative Pressure-Assisted Wound Therapy Device
A study testing Regulated Negative Pressure-Assisted Wound Therapy Device in people with Negative-Pressure Wound Therapy, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Regulated negative pressure-assisted wound therapy (RNPT) is regarded as a gold standard technology for treatment of various chronic and acute wounds. The investigators plan to evaluate the efficacy and ease of use of this device. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Negative-Pressure Wound Therapy
- What is being tested?
- Regulated Negative Pressure-Assisted Wound Therapy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to May 2013
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic or acute wounds
Who cannot join
- Uncontrolled bleeding
- Neoplasms in wound
- Exposed blood vessels
- Exposed internal organs
Trial locations and contacts
1 site in 1 country.
About this study
Regulated negative pressure-assisted wound therapy (RNPT) is regarded as a gold standard technology for treatment of various chronic and acute wounds. The investigators plan to evaluate the efficacy and ease of use of this device.
- Conditions
- Negative-Pressure Wound Therapy
- Being tested
- Regulated Negative Pressure-Assisted Wound Therapy Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulated Negative Pressure-Assisted Wound Therapy DeviceDevice
Negative pressure will be applied in the usual way that is normally applied in our Medical Center
| Study group | Role | What they receive |
|---|---|---|
| Investigated Wounds | Experimental | Not described Receives: Device: Regulated Negative Pressure-Assisted Wound Therapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Measurement of change in wound size
Measured: Ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Negative-Pressure Wound TherapyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603901
- Sponsor's protocol ID
- HYMC-2012-31
- Status last verified
- May 2012
- First submitted
- 20 May 2012
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulated Negative Pressure-Assisted Wound Therapy Device
- ClinicalTrials.gov ID
- NCT01603901
- Acronym / sponsor ID
- HYMC-2012-31
- Conditions
- Negative-Pressure Wound Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 23 May 2012 (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.
Regulated negative pressure-assisted wound therapy (RNPT) is regarded as a gold standard technology for treatment of various chronic and acute wounds. The investigators plan to evaluate the efficacy and ease of use of this device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigated Wounds | Experimental | Device: Regulated Negative Pressure-Assisted Wound Therapy Device |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic or acute wounds
Key exclusion criteria (4 listed)
- Uncontrolled bleeding
- Neoplasms in wound
- Exposed blood vessels
- Exposed internal organs
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 |
|---|---|---|
| Regulated Negative Pressure-Assisted Wound Therapy DeviceNegative pressure will be applied in the usual way that is normally applied in our Medical Center | Device | Investigated Wounds |
Primary outcome
Efficacy
Time frame: Ten days
Measurement of change in wound size
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulated Negative Pressure-Assisted Wound Therapy Device in people with Negative-Pressure Wound Therapy, 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 4 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 23 May 2012. 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 (972-4-6304689, plastic_surg@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (time frame: Ten 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 23 May 2012.