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New wound dressing may cut infection risk after joint revision surgery

NCT ID NCT06661473

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

104 people

The number who actually took part.

Started

Oct 2024

Finished

Dec 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Bon Secours Mercy Health

    Youngstown, Ohio, 45103, United States

  • Life Bridge Health- Sinai Hospital

    Baltimore, Maryland, 21215, United States

  • MedStar Health

    Washington D.C., District of Columbia, 20001, United States

  • Northwell

    Garden City, New York, 11040, United States

  • Ortho Indy

    Indianapolis, Indiana, 46077, United States

  • Spokane Joint Replacement Center

    Spokane, Washington, 99218, United States

  • St. Louis University

    St Louis, Missouri, 63110, United States

  • Twin Cities Orthopedics

    Minneapolis, Minnesota, 55435, United States

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