Clinical trial NCT05924984: Prospective Diagnostic Study on Perforator Localization of Anterolateral Thigh Flap With Perforator Locator
Official title: Prospective Diagnostic Study on Perforator Localization of Anterolateral Thigh Flap With Perforator Locator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Vessel Perforation
Keywords: anterolateral thigh flap
locator
computerized tomography
color doppler ultrasound
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: During CT scan, the patient lay in a supine position on the examination bed, 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, the base was extended or shortened according to the length of the patient's thigh, and the iliac patella positioning rod was slipped so that the iliac crest positioning rod was located on the anterior superior spine of the patient's iliac and the patella positioning rod was located on the lateral margin of the patient's patella. And mark the anchor point on the skin with a pen, and mark the skin with a pen. After CT examination, the computer carried out three-dimensional reconstruction of blood vessels, and moved the perforating branch locator rod according to the calculated scale to make it correspond to the scale, and marked the corresponding skin position according to the perforating branch locator rod.
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Sensitivity
timeFrame: during the operation
Secondary outcomes:
measure: positive predictive value
timeFrame: during the operation
measure: negative predictive value
timeFrame: during the operation
measure: Specificity
timeFrame: during the operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: