Negative Pressure Wound Therapy (NPWT) for Infection with Drainage

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anne DeBenedetti, Chicago, ILInfection with DrainageNegative Pressure Wound Therapy (NPWT) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with negative pressure wound therapy (NPWT) versus sterile dressings.

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 90 days

90 days
Cost comparison
Reoperation
Wound complications

Trial Safety

Side Effects for

Antimicrobial Barrier Dressing
4%Wound drainage
2%Irrigation and Debridement
1%Revision Total Knee Arthroplasty
1%Non-healing wound
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT03345771) in the Antimicrobial Barrier Dressing ARM group. Side effects include: Wound drainage with 4%, Irrigation and Debridement with 2%, Revision Total Knee Arthroplasty with 1%, Non-healing wound with 1%.

Trial Design

2 Treatment Groups

Sterile Antimicrobial Dressings
1 of 2
NPWT
1 of 2

Active Control

Experimental Treatment

201 Total Participants · 2 Treatment Groups

Primary Treatment: Negative Pressure Wound Therapy (NPWT) · No Placebo Group · Phase 1

NPWT
Device
Experimental Group · 1 Intervention: Negative Pressure Wound Therapy (NPWT) · Intervention Types: Device
Sterile Antimicrobial Dressings
Device
ActiveComparator Group · 1 Intervention: Sterile Antimicrobial Dressings · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Negative Pressure Wound Therapy (NPWT)
2017
Completed Phase 3
~230

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 90 days

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor
391 Previous Clinical Trials
153,436 Total Patients Enrolled
3MIndustry Sponsor
148 Previous Clinical Trials
31,261 Total Patients Enrolled
Denis Nam, MD, MScPrincipal InvestigatorRush University Medical Center

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You had hip replacement surgery followed by a temporary cement spacer with antibiotics, and now need another hip replacement surgery.
You have had hip replacement surgery in the past because of loosening of the implant or bone damage around it, or you have had to undergo hip replacement surgery again because of a broken bone around the implant. This does not include initial hip replacement surgery or minor surgery to fix a broken bone.

Frequently Asked Questions

What risks do patients face when undergoing Negative Pressure Wound Therapy (NPWT)?

"Due to its limited research on safety and efficacy, Negative Pressure Wound Therapy (NPWT) was scored a 1." - Anonymous Online Contributor

Unverified Answer

Is the enrollment period for this research still available?

"Affirmative. On clinicaltrials.gov, the posted information certified that this trial is actively recruiting participants and requires 201 volunteers to be sourced from 1 medical site. The investigative project was published on April 28th 2017 but underwent a recent update in October of 2022." - Anonymous Online Contributor

Unverified Answer

How many total participants have signed up for this research project?

"Affirmative. The clinicaltrial.gov website implies that this experiment, which was first listed on April 28th 2017, is actively recruiting participants. Approximately 201 individuals are needed from one location for the study to proceed." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.