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Prospective Diagnostic Study on Perforator Localization of Anterolateral Thigh Flap With Perforator Locator

NCT05924984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-09-19

No results posted yet for this study

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 prospective diagnostic phase II clinical study on perforator localization of flap perforator, and explore its effectiveness and accuracy through sensitivity and specificity.

In this study, a total of 76 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 means of 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.

Conditions

  • Blood Vessel Perforation

Interventions

DEVICE

perforator locator

During CT scan, the patient was lying on the examination bed in a supine position, with the patient's toes facing up and fixed with an ankle fixator, the perforator was placed on the outside of the patient's thigh, and the base was extended or shortened according to the length of the patient's thigh, so that the iliac pole was located on the anterior superior spine of the patient's iliac and the patella pole was located on the lateral border of the patient's patella, and the positioning point was marked on the skin with a pen. After CT examination, the position of the perforating branch was displayed after 3D reconstruction of blood vessels by computer, and the position of the perforating branch was calculated using the computer position. The perforating branch positioning rod was moved according to the calculated scale to make it correspond to the scale, and the corresponding skin position mark was made according to the perforating branch positioning rod.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-22
Primary Completion
2024-03-22
Completion
2024-04-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05924984 on ClinicalTrials.gov