Alternating Pressure Air Mattress and Pressure Injury Pre... | NCT06151327

Studies
Alternating Pressure Air Mattress and Pressure Injury Prevalence

NCT06151327

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Nov 30, 2023Actual

Enrollment

50,419Actual

Phase

Not provided

Conditions

Pressure Injury
Alternating Pressure Air Mattress
Implementation

Interventions

Not provided

Countries

Taiwan

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 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2023Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Nov 1, 2023Actual

First Submitted Date

Nov 21, 2023

First Submission Date that Met QC Criteria

Nov 21, 2023

First Posted Date

Nov 30, 2023Actual

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

Nov 21, 2023

Last Update Posted Date

Nov 30, 2023Actual

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

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

50,419Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proportion of full thickness pressure injury	total number of full thickness pressure injuries devided by total number of pressure injuries	2020/1 ~2023/8

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with pressure injury

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

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

patients in hospital with pressure injury

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hui-Hsiu Chang	National Taiwan University Hospital Yunlin brach	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan Universiyt Hospital Yunlin Branch		Douliu	Yunlin		Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003668	Pressure Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided