Effect of Regulated Oxygen-Enriched Negative Pressure The... | NCT02357628

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

NCT02357628

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Feb 6, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Wounds and Injuries

Interventions

Wound treatment with RO-NPT
Wound Irrigation

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Mar 2017Estimated

Completion Date

Mar 2017Estimated

First Submitted Date

Feb 3, 2015

First Submission Date that Met QC Criteria

Feb 5, 2015

First Posted Date

Feb 6, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2015

Last Update Posted Date

Feb 6, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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-NPT Device: Wound Irrigation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Wound treatment with RO-NPT	Device		Research Group I Research Group II Research Group III	Oxygen-enriched vacuum therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with hard-to-heal wounds

Exclusion Criteria:

Everyone else

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Moris Topaz, MD, PhD	Contact	972-4-630-4689		mtopazmd@yahoo.com

Overall Officials

Name	Affiliation	Role
Moris Topaz, MD, Phd	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided