CompletedNot Applicable

Interventional Study Exploring the Occurrence of Surgical Site Infections.

United States104 participantsStarted 2024-10-03

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

Incidence of surgical site infections

Timeframe: 90 days from revision surgery

NCT IDNCT06661473

SponsorMolnlycke Health Care AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-23

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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