Interventional Study Exploring the Occurrence of Surgical Site Infections.

NCT06661473 | Completed FDA Device

• 1 other identifier: Asolo SSC
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Total Knee Arthroplasty; Total Hip Arthroplasty Revision; Total Knee Arthroplasty Revision

Keywords

high risk TKA revision; high risk THA revision; NPWT

Outcome Measures

Primary Outcomes (1)

• Incidence of surgical site infections

  90 days from revision surgery

Study Arms (1)

Avance Solo ciNPT

OTHER

Device: Avance Solo Negative Pressure Wound Therapy

Interventions

Avance Solo Negative Pressure Wound Therapy DEVICE

Avance Solo NPWT 7-14 days after high-risk revision TKA or THA.

Avance Solo ciNPT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Use of surgical glue as part of incisional closure method
• Patients who in the opinion of the investigator may not complete or comply with follow up treatment for any reason
• 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.
• Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (8)

MedStar Health

Washington D.C., District of Columbia, 20001, United States

Location

Ortho Indy

Indianapolis, Indiana, 46077, United States

Location

Life Bridge Health- Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Twin Cities Orthopedics

Minneapolis, Minnesota, 55435, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

Northwell

Garden City, New York, 11040, United States

Location

Bon Secours Mercy Health

Youngstown, Ohio, 45103, United States

Location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 28, 2024
• Study Start: October 3, 2024
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: March 31, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)