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NCT05441293 Clinical Trial

Determinants of the Success of Flap Reconstruction: Outcome Analysis of 484 Surgeries for Pressure Injury

Pressure Injury Clinical Trial

Official title:
b Division of Plastic Surgery, Department of Surgery, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05441293
Other study ID # WanFangW2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date May 31, 2022

Study information
Verified date June 2022
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 484
Est. completion date May 31, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: all patients who received debridement or flap reconstruction surgery for Pressure injury in Wan Fang Hospital from January 2016 to December 2021 Exclusion Criteria: the patients who did not received debridement or flap reconstruction surgery for Pressure injury

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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