Effect of Regulated Oxygen-Enriched Negative Pressure Therapy (RO-NPT) On Soft Tissue Wound Repair

February 5, 2015 updated by: Hillel Yaffe Medical Center
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • Patients with hard-to-heal wounds

Exclusion Criteria:

  • Everyone else

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Research Group I
Wound treatment with RO-NPT 40%
Device: Wound treatment with RO-NPT
Other Names:
  • Oxygen-enriched vacuum therapy
Research Group II
Wound treatment with RO-NPT 60%
Device: Wound treatment with RO-NPT
Other Names:
  • Oxygen-enriched vacuum therapy
Research Group III
Wound treatment with RO-NPT 40% and irrigation
Device: Wound treatment with RO-NPT
Other Names:
  • Oxygen-enriched vacuum therapy
Device: Wound Irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Closure
Time Frame: One Month
Before treatment and after treatment wound area measurements will indicate percentage of closure
One Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Moris Topaz, MD, Phd, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

February 3, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Estimate)

February 6, 2015

Last Update Submitted That Met QC Criteria

February 5, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0078-14-HYMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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