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NOT YET RECRUITING
NCT07533292
PHASE3

Bacteriophage Therapy for Orthopedic Implant-Associated Infections

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

A Prospective, Single-Center, Single-Arm Clinical Study with a Pre-Post Self-Controlled Design Evaluating the Efficacy and Safety of Bacteriophage Therapy for Refractory Orthopedic Implant-Associated Infections

Official title: Prospective, Single-Center, Single-Arm, Pre-Post Self-Controlled Study Evaluating the Efficacy and Safety of Bacteriophage Therapy in Orthopedic Implant-Associated Infections

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04-05

Completion Date

2030-12-31

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

bacteriophage preparation

After undergoing standard surgical debridement for orthopedic implant-associated infection. Bacteriophage preparation was administered primarily via postoperative indwelling catheter infusion. An appropriate volume of bacteriophage solution (adjusted according to joint cavity size and clinical assessment) was instilled directly through the catheter into the infected site, twice daily (bid) for 3 consecutive days per treatment cycle. During administration, strict aseptic procedures were maintained, and the distribution of the bacteriophage preparation within the joint cavity was ensured. Throughout the treatment period, patients were closely monitored for local and systemic adverse events related to bacteriophage therapy.

Locations (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China