Total Knee ArthroplastyNCT06661473
Interventional Study Exploring the Occurrence of Surgical Site Infections.
A study testing Avance Solo Negative Pressure Wound Therapy in people with Total Knee Arthroplasty and Total Hip Arthroplasty Revision, run by Molnlycke Health Care AB at 8 sites in United States.
Trial summary
Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Total Hip Arthroplasty Revision, Total Knee Arthroplasty Revision
- What is being tested?
- Avance Solo Negative Pressure Wound Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 Oct 2024to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Patient ≥ 18 years
- Elective unilateral revision THA or TKA.
- High risk patients for surgical wound complications as deemed by investigators
- Primary closure technique by suture or staples
- Linear or curvilinear incisions ≤ 25 cm in length
- The patient able to understand the study and is willing to consent to the clinical investigation
- Patients able to understand how to operate with the negative pressure system at home
Who cannot join
- The need for emergency surgery
- Multiple Incision Approach at the time of surgery (alternative approach from primary surgery using 1 incision is permitted)
- Patients requiring bilateral revision total hip or knee arthroplasty surgery
- Active infections of the offending joint.
- History of multiple infections in the offending joint
- Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and superabsorbent powders (polyacrylates) (within the dressing)
Show all 14Show fewer
- Subjects with contraindications (as per the Avance Solo Instructions for use)
- Pregnant, breastfeeding females, or females of childbearing potential not willing to use contraception for the duration of the investigation
- Patients with presence of remote skin infection or active systemic infection at the time of revision surgery.
- Patient with incisions > 25cm in length or type of incisions that cannot be sufficiently covered by Avance Solo Border dressing (i.e., the wound pad does not overlap the edges of the incision by at least 1.5 cm as per the IFU)
- Use of surgical glue as part of incisional closure method
- Patients who in the opinion of the investigator may not complete or comply with follow up treatment for any reason
- Patients participating in ongoing clinical investigations, or during the past 30 days, that may impact the outcome of this investigation based on the judgement of the investigator.
- Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Life Bridge Health- Sinai Hospital
Baltimore, Maryland, 21215
Northwell
Garden City, New York, 11040
Ortho Indy
Indianapolis, Indiana, 46077
Twin Cities Orthopedics
Minneapolis, Minnesota, 55435
Spokane Joint Replacement Center
Spokane, Washington, 99218
St. Louis University
St Louis, Missouri, 63110
MedStar Health
Washington D.C., District of Columbia, 20001
Bon Secours Mercy Health
Youngstown, Ohio, 45103
About this study
Official title: An Interventional Study to Explore the Occurrence of Surgical Site Complications in High-risk Patients After Revision of Total Hip or Knee Joint Arthroplasty Receiving Closed Incision Negative Pressure Wound Therapy.
Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT.
- Conditions
- Total Knee Arthroplasty, Total Hip Arthroplasty Revision, Total Knee Arthroplasty Revision
- Being tested
- Avance Solo Negative Pressure Wound Therapy
- Keywords
- high risk TKA revision, high risk THA revision, NPWT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avance Solo Negative Pressure Wound TherapyDevice
Avance Solo NPWT 7-14 days after high-risk revision TKA or THA.
| Study group | Role | What they receive |
|---|---|---|
| Avance Solo ciNPT | Other | Not described Receives: Device: Avance Solo Negative Pressure Wound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infections
Measured: 90 days from revision surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start3 Oct 2024
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661473
- Sponsor's protocol ID
- Asolo SSC
- Status last verified
- Dec 2025
- First submitted
- 23 Oct 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study to Explore the Occurrence of Surgical Site Complications in High-risk Patients After Revision of Total Hip or Knee Joint Arthroplasty Receiving Closed Incision Negative Pressure Wound Therapy.
- ClinicalTrials.gov ID
- NCT06661473
- Acronym / sponsor ID
- Asolo SSC
- Conditions
- Total Knee Arthroplasty, Total Hip Arthroplasty Revision, Total Knee Arthroplasty Revision
- Keywords
- high risk TKA revision, high risk THA revision, NPWT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avance Solo ciNPT | Other | Device: Avance Solo Negative Pressure Wound Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent
- Patient ≥ 18 years
- Elective unilateral revision THA or TKA.
- High risk patients for surgical wound complications as deemed by investigators
- Primary closure technique by suture or staples
Key exclusion criteria (14 listed)
- The need for emergency surgery
- Multiple Incision Approach at the time of surgery (alternative approach from primary surgery using 1 incision is permitted)
- Patients requiring bilateral revision total hip or knee arthroplasty surgery
- Active infections of the offending joint.
- History of multiple infections in the offending joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avance Solo Negative Pressure Wound TherapyAvance Solo NPWT 7-14 days after high-risk revision TKA or THA. | Device | Avance Solo ciNPT |
Primary outcome
Incidence of surgical site infections
Time frame: 90 days from revision surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avance Solo Negative Pressure Wound Therapy in people with Total Knee Arthroplasty and Total Hip Arthroplasty Revision, run by Molnlycke Health Care AB at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infections (time frame: 90 days from revision surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.