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Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty

NCT03274466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2024-10-16

Study results available
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Summary

This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care dressing.

Conditions

  • Surgical Wound
  • Revision Total Knee Arthroplasty
  • Wounds and Injuries
  • Joint Disease
  • Musculoskeletal Disease
  • Prosthesis-Related Infections
  • Infection
  • Postoperative Complications
  • Pathologic Processes

Interventions

DEVICE

Closed Incision Negative Pressure Therapy (ciNPT)

Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.

DEVICE

Standard of Care Dressing

A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • KCI USA, Inc

    lead INDUSTRY

Principal Investigators

  • Carlos Higuera, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-05
Primary Completion
2019-11-27
Completion
2019-12-19
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 NCT03274466 on ClinicalTrials.gov