Interventional Study Exploring the Occurrence of Surgical Site Infections.

March 30, 2026 updated by: Molnlycke Health Care AB

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20001
        • Medstar Health
    • Indiana
      • Indianapolis, Indiana, United States, 46077
        • Ortho Indy
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Life Bridge Health- Sinai Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • Twin Cities Orthopedics
    • Missouri
      • St Louis, Missouri, United States, 63110
        • St. Louis University
    • New York
      • Garden City, New York, United States, 11040
        • NorthWell
    • Ohio
      • Youngstown, Ohio, United States, 45103
        • Bon Secours Mercy Health
    • Washington
      • Spokane, Washington, United States, 99218
        • Spokane Joint Replacement Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Avance Solo ciNPT
Device: Avance Solo Negative Pressure Wound Therapy
Avance Solo NPWT 7-14 days after high-risk revision TKA or THA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of surgical site infections
Time Frame: 90 days from revision surgery
90 days from revision surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Molnlycke Health Care AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2024

Primary Completion (Actual)

December 23, 2025

Study Completion (Actual)

December 23, 2025

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Asolo SSC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe