Analysis of Clinical Application of China's First Batch of TYRX Absorbable Antibacterial Envelope

Active, not recruiting

• Conditions: CIED Infection; TYRX Absorbable Antibacterial Envelope

• Registration Number: NCT06710873
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

This study is the first to use TYRX domesticly, reporting and summarizing its usage to validate its real-world effectiveness in CIED infection prevention.

Detailed Description

This study is the first to use TYRX domesticly, reporting and summarizing its usage to validate its real-world effectiveness in CIED infection prevention.

Study Timeline

• Study Start: 2023-12-01
• Primary Completion: 2024-10-09
• Status Verified: 2024-11
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Study First Posted: 2024-11-29
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All patients who received the TYRX absorbable antimicrobial envelopes at our hospital from December 2023 to September 2024

Exclusion Criteria

• Allergies to the envelope materials or antimicrobial drugs (minocycline and other tetracyclines, rifampin)
• Existing infections at the CIED implantation site
• Pregnant or breastfeeding women
• children and adolescents

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CIED infection	three months post-surgery	The infection rate related to CIEDs at three months post-surgery

Trial Locations

Locations (1)

Sun-Yatsen Memorial Hospital of Sun-Yatsen University; 🇨🇳 Guangzhou, Guangdong, China