Clinical trial NCT06661473: Interventional Study Exploring the Occurrence of Surgical Site Infections.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Total Hip Arthroplasty Revision
Total Knee Arthroplasty Revision
Keywords: high risk TKA revision
high risk THA revision
NPWT
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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

Primary outcomes:
measure: Incidence of surgical site infections
timeFrame: 90 days from revision surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Health
state: District of Columbia
city: Tampa
country: United States
facility: FORE
state: Florida
city: Indianapolis
country: United States
facility: Ortho Indy
state: Indiana
city: Minneapolis
country: United States
facility: Twin Cities Orthopedics
state: Minnesota
city: St. Louis
country: United States
facility: St. Louis University
state: Missouri
city: Garden City
country: United States
facility: Northwell
state: New York
city: Youngstown
country: United States
facility: Bon Secours Mercy Health
state: Ohio
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
References: