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Completed

NCT Number: NCT06661473

Interventional Study Exploring the Occurrence of Surgical Site Infections.

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MedStar Health, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Avance Solo Negative Pressure Wound Therapy

Device

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

Primary outcomes

  1. Incidence of surgical site infections

    Time frame: 90 days from revision surgery

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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