Analysis of Clinical Application of China's First Batch o... | NCT06710873

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

NCT06710873

Sponsor

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

Status

Active, not recruiting

Last Update Posted

Mar 25, 2025Actual

Enrollment

50Actual

Phase

Not provided

Conditions

CIED Infection
TYRX Absorbable Antibacterial Envelope

Interventions

TYRX Absorbable Antibacterial Envelope

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Oct 9, 2024Actual

Completion Date

Mar 1, 2026Estimated

First Submitted Date

Nov 26, 2024

First Submission Date that Met QC Criteria

Nov 26, 2024

First Posted Date

Nov 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2025

Last Update Posted Date

Mar 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TYRX Absorbable Antibacterial Envelope	Device	All enrolled patients will receive the TYRX Absorbable Antibacterial Envelope implanted simultaneously during the CIED surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CIED infection	The infection rate related to CIEDs at three months post-surgery	three months post-surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun-Yatsen Memorial Hospital of Sun-Yatsen University		Guangzhou	Guangdong	510030	China