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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 belowSelect...
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
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 • NCT033457714%
Wound drainage
2%
Irrigation and Debridement
1%
Revision Total Knee Arthroplasty
1%
Non-healing wound
100%
80%
60%
40%
20%
0%
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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
436 Previous Clinical Trials
249,051 Total Patients Enrolled
10 Trials studying Infections
9,286 Patients Enrolled for Infections
3MIndustry Sponsor
158 Previous Clinical Trials
31,283 Total Patients Enrolled
12 Trials studying Infections
7,147 Patients Enrolled for Infections
Denis Nam, MD, MScPrincipal InvestigatorRush University Medical Center