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NPWT vs Conventional Dressings for Hip Surgery Recovery

Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

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.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Wound complications
Secondary outcome measures
Cost comparison
Reoperation

Side effects data

From 2021 Phase 3 trial • 230 Patients • NCT03345771
4%
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

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
419 Previous Clinical Trials
162,798 Total Patients Enrolled
10 Trials studying Infections
9,280 Patients Enrolled for Infections
3MIndustry Sponsor
157 Previous Clinical Trials
31,143 Total Patients Enrolled
12 Trials studying Infections
7,017 Patients Enrolled for Infections
Denis Nam, MD, MScPrincipal InvestigatorRush University Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~5 spots leftby Jun 2024