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.

Molnlycke Health Care AB8 sites in 1 country105 target enrollmentOctober 3, 2024

Overview

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

Registry

clinicaltrials.gov

Start Date

October 3, 2024

End Date

January 1, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Molnlycke Health Care AB

Responsible Party

Sponsor

•Written informed consent
•Patient ≥ 18 years
•Elective unilateral revision THA or TKA.
•High risk patients for surgical wound complications as deemed by investigators
•Primary closure technique by suture or staples
•Linear or curvilinear incisions ≤ 25 cm in length
•The patient able to understand the study and is willing to consent to the clinical investigation
•Patients able to understand how to operate with the negative pressure system at home

•The need for emergency surgery
•Multiple Incision Approach at the time of surgery (alternative approach from primary surgery using 1 incision is permitted)
•Patients requiring bilateral revision total hip or knee arthroplasty surgery
•Active infections of the offending joint.
•History of multiple infections in the offending joint
•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)
•Subjects with contraindications (as per the Avance Solo Instructions for use)
•Pregnant, breastfeeding females, or females of childbearing potential not willing to use contraception for the duration of the investigation
•Patients with presence of remote skin infection or active systemic infection at the time of revision surgery.
•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)