Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06277687
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2024-02-19
Brief Title:
Exploratory Study on the Application of Virtual Augmented Reality Combined With Finder in Preoperative Anterolateral Thigh Flap Perforator Positioning
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Exploratory Study on the Application of Virtual Augmented Reality Combined With Finder in Preoperative Anterolateral Thigh Flap Perforator Positioning
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None