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Evaluating Edema and Range of Motion Using Negative Pressure Therapy vs. Standard Surgical Dressing in Bilateral TKA

NCT04712019 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-01

Study results available
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Summary

This study will compare the effects of closed incision negative pressure dressing vs. standard of care silver dressing on lower limb swelling after bilateral primary total knee arthroplasty.

Conditions

  • Surgical Wound
  • Bilateral Total Knee Arthroplasty
  • Wounds and Injuries
  • Joint Diseases
  • Musculoskeletal Diseases
  • Edema Leg
  • Joint Pain
  • Arthritis Knee

Interventions

DEVICE

Closed Incision Negative Pressure Therapy (ciNPT)

Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision

DEVICE

Standard Silver-containing Dressing

A standard silver-containing dressing applied to a closed surgical incision

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • Solventum US LLC

    lead INDUSTRY

Principal Investigators

  • Fred Cushner, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2022-08-26
Completion
2022-08-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04712019 on ClinicalTrials.gov