Interventional Study Exploring the Occurrence of Surgical Site Infections.

Description

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

Study Overview

Study Details

Study overview

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

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 the Occurrence of Surgical Site Infections.

Condition
Total Knee Arthroplasty
Intervention / Treatment

-

Contacts and Locations

Tampa

FORE, Tampa, Florida, United States, 33606

Indianapolis

Ortho Indy, Indianapolis, Indiana, United States, 46077

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

Minneapolis

Twin Cities Orthopedics, Minneapolis, Minnesota, United States, 55435

Saint Louis

St. Louis University, Saint Louis, Missouri, United States, 63110

Youngstown

Bon Secours Mercy Health, Youngstown, Ohio, United States, 45103

Nashville

St Thomas Hospital, Nashville, Tennessee, United States, 37129

Spokane

Spokane Joint Replacement Center, Spokane, Washington, United States, 99218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Molnlycke Health Care AB,

Study Record Dates

2025-06