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Completed

NCT Number: NCT05441293

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

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.

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Key information

Conditions

Pressure Injury Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flap reconstruction

Procedure

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

Primary outcomes

  1. Complete wound healing

    Time frame: from January 2016 to December 2021

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

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Jul 1, 2022
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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