New wound dressing may cut infection risk after joint revision surgery
NCT ID NCT06661473
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a special vacuum dressing (negative pressure wound therapy) can reduce surgical site infections in high-risk patients undergoing revision hip or knee replacement. 104 patients were enrolled. The goal was to see if this approach lowers complication rates after these complex surgeries.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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104 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written informed consent 2. Patient ≥ 18 years 3. Elective unilateral revision THA or TKA. 4. High risk patients for surgical wound complications as deemed by investigators 5. Primary closure technique by suture or staples 6. Linear or curvilinear incisions ≤ 25 cm in length 7. The patient able to understand the study and is willing to consent to the clinical investigation 8. Patients able to understand how to operate with the negative pressure system at home Exclusion Criteria: 1. The need for emergency surgery 2. Multiple Incision Approach at the time of surgery (alternative approach from primary surgery using 1 incision is permitted) 3. Patients requiring bilateral revision total hip or knee arthroplasty surgery 4. Active infections of the offending joint. 5. History of multiple infections in the offending joint 6. 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) 7. Subjects with contraindications (as per the Avance Solo Instructions for use) 8. Pregnant, breastfeeding females, or females of childbearing potential not willing to use contraception for the duration of the investigation 9. Patients with presence of remote skin infection or active systemic infection at the time of revision surgery. 10. 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) 11. Use of surgical glue as part of incisional closure method 12. Patients who in the opinion of the investigator may not complete or comply with follow up treatment for any reason 13. 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. 14. Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Bon Secours Mercy Health
Youngstown, Ohio, 45103, United States
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Life Bridge Health- Sinai Hospital
Baltimore, Maryland, 21215, United States
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MedStar Health
Washington D.C., District of Columbia, 20001, United States
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Northwell
Garden City, New York, 11040, United States
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Ortho Indy
Indianapolis, Indiana, 46077, United States
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Spokane Joint Replacement Center
Spokane, Washington, 99218, United States
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St. Louis University
St Louis, Missouri, 63110, United States
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Twin Cities Orthopedics
Minneapolis, Minnesota, 55435, United States
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