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

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.

Study Overview

• Status: Completed
• Conditions: Blood Vessel Perforation
• Intervention / Treatment: Device: perforator locator

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: perforator localization; CT and color Doppler ultrasound were used to locate the perforating branch of the descending branch of the lateral circumflex femoral artery, and the position of the perforator was compared with real perforator respectively during the operation.

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.; Other Names: color Doppler ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	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)	during the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	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)	during the operation
positive predictive value	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)	during the operation
negative predictive value	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)	during the operation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Actual): March 22, 2024
• Study Completion (Actual): April 20, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: color doppler ultrasound; computerized tomography; locator; anterolateral thigh flap
• Other Study ID Numbers: SYSKY-2023-391-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No