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NCT01603901 Clinical Trial

Regulated Negative Pressure-Assisted Wound Therapy Device

Negative-Pressure Wound Therapy Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01603901
Other study ID # HYMC-2012-31
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 20, 2012
Last updated May 22, 2012
Start date June 2012
Est. completion date May 2013

Study information
Verified date May 2012
Source Hillel Yaffe Medical Center
Contact Moris Topaz, MD, PhD
Phone 972-4-6304689
Email plastic_surg@hy.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date May 2013
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Chronic or acute wounds

Exclusion Criteria:

- Uncontrolled bleeding

- Neoplasms in wound

- Exposed blood vessels

- Exposed internal organs

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Regulated Negative Pressure-Assisted Wound Therapy Device
Negative pressure will be applied in the usual way that is normally applied in our Medical Center

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 Efficacy Measurement of change in wound size Ten days No
See also
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Completed NCT02682316 - Negative Pressure Wound Therapy in Post-Operative Incision Management Phase 3
Recruiting NCT05716503 - Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds N/A
Recruiting NCT02901613 - Prophylactic Post-Cesarean Incisional Negative-pressure Wound Therapy in Morbidly Obese Patients N/A
Completed NCT02526342 - Impact of Negative Pressure Wound Therapy on Free Muscle Flaps N/A
Withdrawn NCT03566641 - Negative Pressure Wound Therapy vs Standard Care Dressing N/A