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Completed

NCT Number: NCT06277687

Exploratory Study on the Application of Virtual Augmented Reality Combined With Finder in Preoperative Anterolateral Thigh Flap Perforator Positioning

Oral and maxillofacial region is an important anatomical part of human body, responsible for chewing, swallowing, language, expression, breathing and other physiological functions. The tissue defects in this area not only seriously affect the physiological function, but also lead to facial deformity and aesthetic damage, affecting the quality of life of patients. The anterolateral thigh flap has become one of the main methods for defect repair due to its large tissue volume and high survival rate, and one of the key steps to ensure a high survival rate is the location of the perforator. How to find the perforator more accurately by improving the detection scheme or locating the perforator according to the anatomical structure, and guide the preparation and cutting of the flap, is the main direction of current research. This study intends to conduct a exploratory study on perforator localization of flap , and explore its effectiveness and accuracy through sensitivity and specificity.

In this study, a total of 24 patients with maxillofacial defects caused by tumors, trauma and other reasons requiring anterolateral femoral flap repair were included, and the perforator branch of femoral anterolateral flap was positioned preoperatively by Virtual augmented reality combined with perforator positioning device and color Doppler ultrasound. After the anterolateral thigh flap was prepared, the incision was closed in the donor area of the leg, and the flap was transplanted free to the maxillofacial defect area for repair. The sensitivity, specificity, positive predictive value, negative predictive value, distance difference and odds ratio of the two methods were calculated respectively, and the differences of each evaluation index between the two groups were compared, mainly to evaluate the sensitivity and specificity between the two groups.

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Key information

Conditions

Blood Vessel Perforation

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guanzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients with oral and maxillofacial defects caused by malignant tumors or trauma require anterior lateral femoral skin flap repair after surgery
  • There is no history of leg trauma and surgery is feasible
  • No clinically significant positive signs were found in physical examination
  • No chronic or current illnesses such as heart, liver, pancreas, spleen, kidney, digestive tract, respiratory, blood, nervous system, etc
  • No abnormalities found in electrocardiogram (ECG) and X-ray film
  • Hepatitis B surface antigen (HBSAg), anti hepatitis C antibody (anti HCV), anti human immunodeficiency virus antibody (anti HIV), and negative Treponema pallidum (TP)
  • No clinically significant abnormalities were found in vital signs, blood routine, urine routine, blood biochemistry, and blood pregnancy tests
  • The patient voluntarily participated in this study and signed an informed consent form

Exclusion criteria

  • Have a history of leg injury or surgery
  • Significant abnormalities in blood routine, heart, lung, liver, and kidney functions, insufficient compensatory function, or severe systemic diseases
  • Pregnant or lactating women, or those planning to conceive within six months
  • Individuals with a history of mental illness who cannot cooperate with the examination
  • Individuals with allergic constitution or known allergies to contrast agent ingredients
  • The patient or guardian refuses to sign a written consent form

Treatment and study plan

Virtual Augmented Reality Combined With Finder

Diagnostic Test

After CT examination, the computer carried out three-dimensional reconstruction of blood vessels, and input the CTA data into Cinematic Anatomy reconstruction software to analyze blood vessels, Muscles and other tissues are reconstructed in three dimensions. Before the operation, the Finder is used to restore the position of the thigh during CTA examination. The Hololens is used to match the reconstructed three-dimensional image with the perforator locator and the thigh. Before the operation, the pedicles of the descending branches of the lateral arteries and the perforating vessels are marked on the skin of the thigh to achieve the positioning and marking of the perforating branches.

Other names: Color Doppler ultrasound

Primary outcomes

  1. Sensitivity

    Time frame: during the operation

    The percentage of actual perforating branches that are correctly determined as the perforating branches according to this research method (true positive rate) is calculated as follows: number of true positive perforations /(number of true positive perforations + number of false negative perforations) =TP/(TP+FN)

  2. Specificity

    Time frame: during the operation

    The percentage of actual no perforations correctly judged as no perforations according to this research method (true negative rate) is calculated as follows: true negative number /(true negative perforations + false positive perforations) =TN/(TN+FP)

Secondary outcomes

  1. positive predictive value

    Time frame: during the operation

    The proportion of true positivity in the number of positive perforations determined by this research method reflects the probability that the subject does have perforations when the diagnostic method to be evaluated is determined to be positive. The calculation formula is as follows: PV+ = number of true positive perforations/total number of perforations =TP/(TP+FP)

  2. negative predictive value

    Time frame: during the operation

    The proportion of true negative in the number of negative non-penetrating counts determined by the research method; If the diagnostic method to be evaluated is judged negative, the probability that the subject has no negative is calculated as follows: PV- = number of true negative penetrations/total number of controls =TN/(FN+TN)

  3. Youden Index

    Time frame: during the operation

    Defined as the total ability to find the correct perforating branches and to judge the absence of perforating branches, is the sum of sensitivity and specificity minus 1

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Sep 19, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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