NCT01603901

Brief 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.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

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

May 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

2 months

First QC Date

May 20, 2012

Last Update Submit

May 22, 2012

Conditions

Negative-Pressure Wound Therapy

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    Measurement of change in wound size

    Ten days

Study Arms (1)

Investigated Wounds

EXPERIMENTAL
Device: Regulated Negative Pressure-Assisted Wound Therapy Device

Interventions

Regulated Negative Pressure-Assisted Wound Therapy DeviceDEVICE

Negative pressure will be applied in the usual way that is normally applied in our Medical Center

Investigated Wounds

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic or acute wounds

You may not qualify if:

  • Uncontrolled bleeding
  • Neoplasms in wound
  • Exposed blood vessels
  • Exposed internal organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Central Study Contacts

Moris Topaz, MD, PhD

CONTACT

972-4-6304689plastic_surg@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2012

First Posted

May 23, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

May 1, 2013

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

IL(1)