NCT05441293

Brief Summary

Background: Pressure injury (PI) mainly occurs in bedridden older adults or those with physical limitations. PI treatment is typically long-term, requiring coordination between health-care workers and the patient's caregiver. Here, we aimed to determine the appropriate timing to conduct flap reconstruction in patients with PIs and identify factors affecting surgical outcomes. Materials and Methods: We retrospectively reviewed the data of all patients who received debridement or flap reconstruction surgery for PIs in our hospital from January 2016 to December 2021. The extracted data included patient demographics, surgical records, blood test results, vital signs, and flap outcomes. Next, these characteristics including the flap outcomes of our patients with PIs were analyzed, along with the risk factors for poor wound healing and complications.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
484

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

5.9 years

First QC Date

June 28, 2022

Last Update Submit

June 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Complete wound healing

    no presentation of wound drainage or wound dehiscence at the surgical site 14 days after drainage tube removal.

    from January 2016 to December 2021

Study Arms (2)

debridements group

During study peroid, the patient who received debridement surgery for pressure injury

Procedure: flap reconstruction

flap reconstructions group

During study peroid, the patient who received flap reconstruction surgery for pressure injury

Procedure: flap reconstruction

Interventions

received flap reconstruction over sacrum, back, trochanter, ischium, elbow, and lower extremities

debridements groupflap reconstructions group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021

You may qualify if:

  • all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021

You may not qualify if:

  • the patients who did not received debridement or flap reconstruction surgery for Pressure injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Design

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

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 1, 2022

Study Start

January 1, 2016

Primary Completion

December 1, 2021

Study Completion

May 31, 2022

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

the data are not available for sharing.