Exploring surgical site infections in high-risk knee and hip revision patients
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.
This study is testing if a special wound therapy can help high-risk patients who have knee or hip surgery avoid infections after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Molnlycke Health Care AB Industry-sponsored |
| Locations | 8 sites (Washington, District of Columbia and 7 other locations) |
| Trial ID | NCT06661473 on ClinicalTrials.gov |
What this trial studies
This interventional study investigates the occurrence of surgical site complications in patients undergoing elective unilateral revision total knee arthroplasty (TKA) or total hip arthroplasty (THA) who are considered high risk for such complications. The study utilizes Avance Solo Negative Pressure Wound Therapy (NPWT) to manage surgical wounds post-operatively. Participants must be able to understand and operate the NPWT system at home, and the study focuses on patients with specific eligibility criteria to ensure safety and efficacy. The goal is to assess the effectiveness of NPWT in reducing infection rates in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing elective unilateral revision TKA or THA and are deemed high risk for surgical wound complications.
Not a fit: Patients requiring emergency surgery, those with active infections, or those needing bilateral revision surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of surgical site infections in high-risk patients undergoing revision arthroplasty.
How similar studies have performed: Other studies utilizing negative pressure wound therapy have shown promising results in reducing surgical site infections, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington, District of Columbia and 7 other locations
- MedStar Health — Washington, District of Columbia, United States (Recruiting)
- Fore — Tampa, Florida, United States (Not_yet_recruiting)
- Ortho Indy — Indianapolis, Indiana, United States (Recruiting)
- Twin Cities Orthopedics — Minneapolis, Minnesota, United States (Recruiting)
- St. Louis University — St. Louis, Missouri, United States (Not_yet_recruiting)
- Northwell — Garden City, New York, United States (Recruiting)
- Bon Secours Mercy Health — Youngstown, Ohio, United States (Not_yet_recruiting)
- Spokane Joint Replacement Center — Spokane, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer O'Connell, Sr. Clinical Project Manager
- Email: jennifer.oconnell@molnlycke.com
- Phone: 470-694-0750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.