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Negative Pressure Wound Therapy
Negative Pressure Wound Therapy for Knee and Hip Replacement
N/A
Recruiting
Research Sponsored by Molnlycke Health Care AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must be 18 years or older
Elective unilateral revision total hip arthroplasty (THA) or total knee arthroplasty (TKA)
Must not have
Active infections of the offending joint
Need for emergency surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial is investigating how often surgical site complications occur in high-risk patients undergoing knee or hip replacement surgery using a specific type of wound therapy."
Who is the study for?
This trial is for high-risk patients who are undergoing a second (revision) knee or hip replacement surgery. It's not specified who can't join the trial, but typically, people with certain health conditions or those who don't meet the study requirements would be excluded.
What is being tested?
The study is testing whether using Avance Solo Negative Pressure Wound Therapy (NPWT) can reduce surgical site infections in patients having revision total knee or hip replacements.
What are the potential side effects?
While specific side effects aren't listed, NPWT systems like Avance Solo may cause skin irritation, discomfort at the application site, or rarely could lead to further complications if not monitored properly.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am scheduled for a hip or knee replacement revision surgery.
Select...
My surgical wound was closed with stitches or staples.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an infection in the joint causing my problems.
Select...
I need surgery urgently.
Select...
I need surgery to fix both of my hip or knee replacements.
Select...
I have a skin infection or another infection in my body at the time of my planned surgery.
Select...
I have had several infections in one of my joints.
Select...
I am not pregnant or breastfeeding and willing to use contraception if of childbearing age.
Select...
My surgical cut is longer than 25 cm or can't be fully covered by a specific dressing.
Select...
My surgery incisions were closed with surgical glue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Avance Solo ciNPTExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Molnlycke Health Care ABLead Sponsor
56 Previous Clinical Trials
7,839 Total Patients Enrolled