NCT02357628

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 6, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

February 3, 2015

Last Update Submit

February 5, 2015

Conditions

Wounds and Injuries

Outcome Measures

Primary Outcomes (1)

  • Wound Closure

    Before treatment and after treatment wound area measurements will indicate percentage of closure

    One Month

Study Arms (3)

Research Group I

Wound treatment with RO-NPT 40%

Device: Wound treatment with RO-NPT

Research Group II

Wound treatment with RO-NPT 60%

Device: Wound treatment with RO-NPT

Research Group III

Wound treatment with RO-NPT 40% and irrigation

Device: Wound treatment with RO-NPTDevice: Wound Irrigation

Interventions

Wound treatment with RO-NPTDEVICE
Also known as: Oxygen-enriched vacuum therapy
Research Group IResearch Group IIResearch Group III
Wound IrrigationDEVICE
Research Group III

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Patients with hard-to-heal wounds

You may not qualify if:

  • Everyone else

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Moris Topaz, MD, Phd

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moris Topaz, MD, PhD

CONTACT

972-4-630-4689mtopazmd@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 6, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

February 6, 2015

Record last verified: 2015-02

Locations

IL(1)