NCT06710873

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 26, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 25, 2025

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

November 26, 2024

Last Update Submit

March 20, 2025

Conditions

CIED InfectionTYRX Absorbable Antibacterial Envelope

Outcome Measures

Primary Outcomes (1)

  • CIED infection

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

    three months post-surgery

Interventions

TYRX Absorbable Antibacterial EnvelopeDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun-Yatsen Memorial Hospital of Sun-Yatsen University

Guangzhou, Guangdong, 510030, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2024

First Posted

November 29, 2024

Study Start

December 1, 2023

Primary Completion

October 9, 2024

Study Completion

March 1, 2026

Last Updated

March 25, 2025

Record last verified: 2024-11

Locations

CN(1)