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Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA

NCT03321799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2025-08-06

No results posted yet for this study

Summary

Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with negative pressure wound therapy (NPWT) versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing.

Conditions

  • Infection, Drainage

Interventions

DEVICE

Negative Pressure Wound Therapy (NPWT)

A computer randomization system will be used on the day of surgery to allocate patients to either the conventional or NPWT dressing. Due to the nature of this study, blinding of patients and surgeons to their allocated cohort will not be possible.

DEVICE

Sterile Antimicrobial Dressings

Control group, current hospital standard.

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Denis Nam, MD, MSc · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-28
Primary Completion
2024-03-14
Completion
2025-07-11
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03321799 on ClinicalTrials.gov