Blood Vessel PerforationNCT05924984
Prospective Diagnostic Study on Perforator Localization of Anterolateral Thigh Flap With Perforator Locator
A study testing perforator locator in people with Blood Vessel Perforation, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Oral and maxillofacial region is an important anatomical part of human body, responsible for chewing, swallowing, language, expression, breathing and other physiological functions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Blood Vessel Perforation
- What is being tested?
- perforator locator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2023to 20 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with oral and maxillofacial defects caused by malignant tumors or trauma require anterior lateral femoral skin flap repair after surgery
- There is no history of leg trauma and surgery is feasible
- No clinically significant positive signs were found in physical examination
- No chronic or current illnesses such as heart, liver, pancreas, spleen, kidney, digestive tract, respiratory, blood, nervous system, etc
- No abnormalities found in electrocardiogram (ECG) and X-ray film
- Hepatitis B surface antigen (HBSAg), anti hepatitis C antibody (anti HCV), anti human immunodeficiency virus antibody (anti HIV), and negative Treponema pallidum (TP)
- No clinically significant abnormalities were found in vital signs, blood routine, urine routine, blood biochemistry, and blood pregnancy tests
- The patient voluntarily participated in this study and signed an informed consent form
Who cannot join
- Have a history of leg injury or surgery
- Significant abnormalities in blood routine, heart, lung, liver, and kidney functions, insufficient compensatory function, or severe systemic diseases
- Pregnant or lactating women, or those planning to conceive within six months
- Individuals with a history of mental illness who cannot cooperate with the examination
- Individuals with allergic constitution or known allergies to contrast agent ingredients
- The patient or guardian refuses to sign a written consent form
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
About this study
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
- Being tested
- perforator locator
- Keywords
- anterolateral thigh flap, locator, computerized tomography, color doppler ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perforator locatorDevice
Also called color Doppler ultrasound
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.
| Study group | Role | What they receive |
|---|---|---|
| perforator localization | Experimental | 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. Receives: Device: perforator locator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: during the operation
Secondary outcomes (3)
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)
Measured: 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)
Measured: during the operation
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)
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start22 Jun 2023
- Primary completion22 Mar 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Vessel PerforationStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Fan, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924984
- Sponsor's protocol ID
- SYSKY-2023-391-01
- Status last verified
- Sep 2024
- First submitted
- 21 Jun 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Diagnostic Study on Perforator Localization of Anterolateral Thigh Flap With Perforator Locator
- ClinicalTrials.gov ID
- NCT05924984
- Acronym / sponsor ID
- SYSKY-2023-391-01
- Conditions
- Blood Vessel Perforation
- Keywords
- anterolateral thigh flap, locator, computerized tomography, color doppler ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| perforator localization | Experimental | Device: perforator locatorCT 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All patients with oral and maxillofacial defects caused by malignant tumors or trauma require anterior lateral femoral skin flap repair after surgery
- There is no history of leg trauma and surgery is feasible
- No clinically significant positive signs were found in physical examination
- No chronic or current illnesses such as heart, liver, pancreas, spleen, kidney, digestive tract, respiratory, blood, nervous system, etc
- No abnormalities found in electrocardiogram (ECG) and X-ray film
Key exclusion criteria (6 listed)
- Have a history of leg injury or surgery
- Significant abnormalities in blood routine, heart, lung, liver, and kidney functions, insufficient compensatory function, or severe systemic diseases
- Pregnant or lactating women, or those planning to conceive within six months
- Individuals with a history of mental illness who cannot cooperate with the examination
- Individuals with allergic constitution or known allergies to contrast agent ingredients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perforator locatorAlso: color Doppler ultrasoundDuring 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. | Device | perforator localization |
Primary outcome
Sensitivity
Time frame: during the operation
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)
3 secondary outcomes
positive predictive value
Time frame: during the operation
negative predictive value
Time frame: during the operation
Specificity
Time frame: during the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perforator locator in people with Blood Vessel Perforation, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: during the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.