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

NCT ID: NCT05924984

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-22
• Study Completion Date: 2024-04-20

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

perforator locator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

color Doppler ultrasound

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Song Fan, MD

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSKY-2023-391-01

Identifier Type: -

Identifier Source: org_study_id