Interventional Study Exploring the Occurrence of Surgical Site Infections.

Last updated: May 5, 2025
Sponsor: Molnlycke Health Care AB
Overall Status: Active - Recruiting

Phase

N/A

Condition

Knee Replacement

Treatment

Avance Solo Negative Pressure Wound Therapy

Clinical Study ID

NCT06661473
Asolo SSC
  • Ages > 18
  • All Genders

Study Summary

Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT.

Eligibility Criteria

Inclusion

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 clinicalinvestigation

  8. Patients able to understand how to operate with the negative pressure system at home

Exclusion

Exclusion Criteria:

  1. The need for emergency surgery

  2. Multiple Incision Approach at the time of surgery (alternative approach from primarysurgery 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 andpolyurethane films (direct contact with wound), acrylic adhesives (direct contactwith skin), polyethylene fabrics and superabsorbent powders (polyacrylates) (withinthe dressing)

  7. Subjects with contraindications (as per the Avance Solo Instructions for use)

  8. Pregnant, breastfeeding females, or females of childbearing potential not willing touse contraception for the duration of the investigation

  9. Patients with presence of remote skin infection or active systemic infection at thetime of revision surgery.

  10. Patient with incisions > 25cm in length or type of incisions that cannot besufficiently covered by Avance Solo Border dressing (i.e., the wound pad does notoverlap 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 withfollow up treatment for any reason

  13. Patients participating in ongoing clinical investigations, or during the past 30days, that may impact the outcome of this investigation based on the judgement ofthe investigator.

  14. Any clinically significant condition that, in the investigator's opinion, wouldsignificantly impair the subject's ability to comply with the study

Study Design

Total Participants: 105
Treatment Group(s): 1
Primary Treatment: Avance Solo Negative Pressure Wound Therapy
Phase:
Study Start date:
October 03, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • MedStar Health

    Washington, District of Columbia 20001
    United States

    Active - Recruiting

  • FORE

    Tampa, Florida 33606
    United States

    Site Not Available

  • Ortho Indy

    Indianapolis, Indiana 46077
    United States

    Active - Recruiting

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Twin Cities Orthopedics

    Minneapolis, Minnesota 55435
    United States

    Active - Recruiting

  • St. Louis University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • St. Louis University

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Northwell

    Garden City, New York 11040
    United States

    Active - Recruiting

  • Bon Secours Mercy Health

    Youngstown, Ohio 45103
    United States

    Site Not Available

  • St Thomas Hospital

    Nashville, Tennessee 37129
    United States

    Site Not Available

  • Spokane Joint Replacement Center

    Spokane, Washington 99218
    United States

    Active - Recruiting

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