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NCT02357628 Clinical Trial

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

Wounds and Injuries Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02357628
Other study ID # 0078-14-HYMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 3, 2015
Last updated February 5, 2015
Start date March 2015
Est. completion date March 2017

Study information
Verified date February 2015
Source Hillel Yaffe Medical Center
Contact Moris Topaz, MD, PhD
Phone 972-4-630-4689
Email mtopazmd@yahoo.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with hard-to-heal wounds

Exclusion Criteria:

- Everyone else

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• Wound treatment with RO-NPT

• Wound Irrigation

Locations
Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)
Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wound Closure Before treatment and after treatment wound area measurements will indicate percentage of closure One Month No
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