A New Prediction Mode for Predicting the Risk of Pressure Injury in Patients Undergoing Liver Transplantation

NCT05588271 | Unknown

• 1 other identifier: KY2022-178-B
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric population is at a high-risk of pressure injury (PI). Patients undergoing liver transplantation are more prone to PIs compared with other types of surgery. However, there is a lack of sensitive and specific assessment tools for the risk of PI in patients undergoing liver transplantation. How to accurately predict the incidence of PI in patients undergoing liver transplantation is needs to be urgently eliminated. The study is conducted in the Renji Hospital, School of Medicine, Shanghai Jiaotong University which is the largest liver transplantation center in China.

Conditions

Liver Transplantation

Keywords

Pressure injury; Liver transplantation; Predictive mode

Outcome Measures

Primary Outcomes (1)

• According to The National Pressure Ulcer Advisory Panel (NPUAP) defined the definition and stage of Pressure Injury to Judge whether pressure injury occurs on skin under pressure.

  Definition:A pressure injury is localized damage to the skin and underlying soft tissue usually over a bony prominence or related to a medical or other device. The injury can present as intact skin or an open ulcer and may be painful. The injury occurs as a result of intense and/or prolonged pressure or pressure in combination with shear. The tolerance of soft tissue for pressure and shear may also be affected by microclimate, nutrition, perfusion, co-morbidities and condition of the soft tissue. NPUAP Pressure Injury Stages:stage 1pressure injury: non-blanchable erythema of intact skin; stage 2 pressure injury: partial-thickness skin loss with exposed dermis; stage 3 pressure injury: full-thickness skin loss; stage 4 pressure injury: full-thickness skin and tissue loss; unstageable pressure injury: obscured full-thickness skin and tissue loss; deep tissue pressure injury: persistent non-blanchable deep red, maroon or purple discoloration

  Within 6 hours after operation

Study Arms (2)

Group with PIs

stage 1pressure injury: non-blanchable erythema of intact skin; stage 2 pressure injury: partial-thickness skin loss with exposed dermis; stage 3 pressure injury: full-thickness skin loss; stage 4 pressure injury: full-thickness skin and tissue loss; unstageable pressure injury: obscured full-thickness skin and tissue loss; deep tissue pressure injury: persistent non-blanchable deep red, maroon or purple discoloration

Other: Exposures

Group without PIs

Skin in good condition

Interventions

Exposures OTHER

This study is an observational study.Exposure factors is patients with pressure injury.

Group with PIs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients undergoing liver transplantation surgery

You may qualify if:

• undergoing liver transplantation surgery (i.e., living-donor liver transplantation and deceased donor liver transplantation)
• patients undergoing the first surgery during their hospitalization

You may not qualify if:

• a history of PI before undergoing surgery
• patients with skin disease that could affect observation of skin and the outcome
• patients who died during surgery

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xiaomei Chen, Master

  Renji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zheying Chen, Master

CONTACT

008613601853150; tougao2022@sina.com

Xiaomei Chen, Master

CONTACT

008613918964297; xiaomeichen1989@163.com

Study Design

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

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 20, 2022
• Study Start: October 20, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

CN (1)