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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

CIED Infection TYRX Absorbable Antibacterial Envelope

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun-Yatsen Memorial Hospital of Sun-Yatsen University

Guangzhou, Guangdong, 510030, China

About this study

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

Who can participate

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

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

Treatment and study plan

TYRX Absorbable Antibacterial Envelope

Device

All enrolled patients will receive the TYRX Absorbable Antibacterial Envelope implanted simultaneously during the CIED surgery.

Primary outcomes

CIED infection

Time frame: three months post-surgery

The infection rate related to CIEDs at three months post-surgery

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2026
First posted: Nov 29, 2024
Registry last updated: Mar 25, 2025

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.