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Negative Pressure Wound Therapy
Closed Incision Negative Pressure Therapy (ciNPT) for Arthritis (ENABLE Trial)
N/A
Waitlist Available
Led By Fred Cushner, MD
Research Sponsored by 3M
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily for 4 weeks post-surgery, then weekly for weeks 5-12
Awards & highlights
ENABLE Trial Summary
This trial will compare two methods of dressing wounds after surgery on both knees. One is the standard silver dressing, and the other is a closed incision negative pressure dressing. They will compare the amount of swelling in the legs after the surgery.
Eligible Conditions
- Arthritis
- Knee Arthritis
- Surgical Wound
- Leg swelling
- Wounds and Injuries
- Total Knee Replacement
- Musculoskeletal Disorders
ENABLE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily for 4 weeks post-surgery, then weekly for weeks 5-12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily for 4 weeks post-surgery, then weekly for weeks 5-12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Average pain rating on 0-10 scale
Change in Knee Extension Angle
Change in Knee Flexion Angle
+6 moreENABLE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Closed Incision Negative Pressure Therapy (ciNPT) DressingExperimental Treatment1 Intervention
Prevena Restor Arthro-Form Dressing with Prevena Plus Therapy Unit
Group II: Standard Silver-containing DressingActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Closed Incision Negative Pressure Therapy (ciNPT)
2017
N/A
~300
Find a Location
Who is running the clinical trial?
3MLead Sponsor
157 Previous Clinical Trials
31,334 Total Patients Enrolled
KCI ManufacturingLead Sponsor
Fred Cushner, MDPrincipal InvestigatorHospital for Special Surgery, New York
Frequently Asked Questions
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