Interventional Study Exploring the Occurrence of Surgical Site Infections.

Launched by MOLNLYCKE HEALTH CARE AB · Oct 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the occurrence of surgical site infections in patients who are at high risk for complications after undergoing revision surgeries for total knee or total hip replacements. The researchers are interested in how a special treatment called negative pressure wound therapy (NPWT) can help reduce the chances of infections in these patients. They are currently looking for participants who are between the ages of 18 and 74 and are planning to have elective surgery for a single hip or knee revision.

To be eligible for the trial, patients must be at high risk for complications, meaning they have factors that could make healing more difficult. They must also be able to provide informed consent and understand how to use the negative pressure system at home after their surgery. Participants will have their surgical wounds monitored closely to see if the NPWT helps prevent infections. It’s important to note that patients with certain conditions, such as active infections or those needing emergency surgery, will not be eligible for this study. If you or a loved one are considering this type of surgery and think you might qualify, this trial could offer a valuable opportunity to help improve recovery outcomes.

Gender

ALL

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