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NPWT vs Conventional Dressings for Hip Surgery Recovery

Phase 1

Waitlist Available

Led By Denis Nam, MD, MSc

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients > 18 years of age undergoing a revision total hip arthroplasty procedure including conversion of a prior open hip surgery to a total hip arthroplasty, aseptic revision for component loosening, osteolysis, or revision for periprosthetic fracture, septic revision surgery, reimplantation of a THA following placement of an antibiotic-loaded cement spacer, incision closure without muscle flaps or skin grafting, willingness to undergo randomization and return for all scheduled visits

Be older than 18 years old

Must not have

Patients requiring a muscle flap or skin grafting for wound closure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

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.

Who is the study for?

This trial is for adults over 18 who need a revision of their hip replacement surgery. It's open to those with loose components, bone loss, or fractures needing component changes, and infections treated by various methods. Participants must be able to close the wound normally without grafts and agree to follow-up visits.

What is being tested?

The study compares Negative Pressure Wound Therapy (NPWT) with standard sterile dressings in preventing complications after hip revision surgeries. The goal is to see if NPWT reduces problems like infections and the need for more surgeries better than regular dressings.

What are the potential side effects?

Possible side effects from NPWT may include skin irritation, discomfort at the dressing site, or an allergic reaction if sensitive to adhesive materials used in the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 and need a second hip surgery for various reasons without using muscle flaps or skin grafts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need a muscle flap or skin graft for my wound.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Wound complications

Secondary study objectives

Cost comparison

Reoperation

Side effects data

From 2021 Phase 3 trial • 230 Patients • NCT03345771

Wound drainage

Irrigation and Debridement

Revision Total Knee Arthroplasty

Non-healing wound

100%

80%

60%

40%

20%

Study treatment Arm

Antimicrobial Barrier Dressing

Closed-incision Negative Pressure Therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Negative pressure wound therapy (NPWT)Experimental Treatment1 Intervention

Experimental group. Negative pressure wound therapy bandage applied intra-operatively by a physician on the treatment team. The dressing will be removed after 7 days postoperatively, or if the battery power stops earlier.

Group II: Sterile Antimicrobial DressingsActive Control1 Intervention

Control group, current hospital standard. AQUACEL is left in place for 7 days unless it becomes saturated over 50%, which requires a premature dressing change.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Negative Pressure Wound Therapy (NPWT)

2017

Completed Phase 3

~230

0 / 2Eligibility criteria met