ACTIVE_NOT_RECRUITING

Interventional Study Exploring the Occurrence of Surgical Site Infections.

Conditions

Total Knee Arthroplasty Total Hip Arthroplasty Revision Total Knee Arthroplasty Revision high risk TKA revision high risk THA revision NPWT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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.

Quick Facts

Study Start:2024-10-03

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06661473

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Locations (Sites)

MedStar Health

Washington D.C., District of Columbia, 20001

United States

Ortho Indy

Indianapolis, Indiana, 46077

United States

Life Bridge Health- Sinai Hospital

Baltimore, Maryland, 21215

United States

Twin Cities Orthopedics

Minneapolis, Minnesota, 55435

United States

St. Louis University

St Louis, Missouri, 63110

United States

Northwell

Garden City, New York, 11040

United States

Bon Secours Mercy Health

Youngstown, Ohio, 45103

United States

Spokane Joint Replacement Center

Spokane, Washington, 99218

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-10-03

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-10-03

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

high risk TKA revision
high risk THA revision
NPWT

Additional Relevant MeSH Terms

Total Knee Arthroplasty
Total Hip Arthroplasty Revision
Total Knee Arthroplasty Revision