NCT03192124

Evaluating Bactisure Wound Lavage in Orthopedic Wounds

Evaluating Bactisure Wound Lavage in Cleansing Orthopedic Surgical Wounds

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate a reduction of debris in knee synovial fluid as demonstrated by WBC cell counts before and after irrigation with Bactisure Wound Lavage.

Detailed description

This study will demonstrate a reduction in fluid cell counts in aspirate acquired from primary total knee arthroplasty patients diagnosed with infection. WBC cell counts will be compared before and after articular irrigation with Bactisure Wound Lavage. This study is a prospective, multi-center, single arm study involving orthopedic surgeons skilled and experienced in deep surgical debridement and in I \& D or reoperation (revision) total knee arthroplasty procedures. A maximum of seven study centers will enroll a maximum of 40 subjects.

Conditions

• Infection of Total Knee Joint Prosthesis

Interventions

Type	Name	Description
DEVICE	Bactisure	Level 1 Panel is a quantitative real-time PCR test to detect 12 microbial organisms that may be present in patient specimen (bacteria and fungi) and includes test for resistance factors to vancomycin and methicillin. Microbial DNA in each sample will be sequenced using the Ion Torrent PGM sequencer in order to establish what type of bacterial and fungal species are present.

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-12-22
• Completion: 2019-03-22
• First posted: 2017-06-19
• Last updated: 2020-01-27

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study