Total Hip Arthroplasty Revision, Total Knee Arthroplasty, Total Knee Arthroplasty Revision
Conditions
Keywords
high risk TKA revision, high risk THA revision, NPWT
Brief summary
Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT.
Interventions
DEVICEAvance Solo Negative Pressure Wound Therapy
Avance Solo NPWT 7-14 days after high-risk revision TKA or THA.
Sponsors
Molnlycke Health Care AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of surgical site infections | 90 days from revision surgery |
Countries
United States
Outcome results
None listed