MammaplastyCDUxCTANCT05687006
Accuracy of Deep Inferior Epigastric Artery Perforator Mapping - Color Doppler Ultrasound Versus CT Angiography
A study testing Colour Doppler Ultrasound in people with Mammaplasty, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
Trial summary
The goal of this clinical trial is to compare the accuracy and contribution of Color Doppler Ultrasound (CDU) guided Deep Inferior Epigastric Artery (DIEA) perforator mapping with or without mapping using Computer Tomography angiography (CTA) in women over 18 years undergoing 2021 unilateral or bilateral breast… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammaplasty
- What is being tested?
- Colour Doppler Ultrasound
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- female;
- aged 18 to 65 years;
- undergoing uni- or bilateral breast free flap reconstruction harvested from the lower abdomen;
- signed informed consent to participate in the study.
Who cannot join
- history of allergy to iodinated contrast material;
- history of abdominoplasty;
- Body Mass index > 35;
- active oncological disease ;
- Karnofsky Performance Status < 50;
- change of the reconstructive method as a result of the preoperative mapping;
- non-standard performed CTA examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Deep Inferior Epigastric Artery Perforator Mapping - Color Doppler Ultrasound Versus CT Angiography: A Randomized Controlled Trial
The goal of this clinical trial is to compare the accuracy and contribution of Color Doppler Ultrasound (CDU) guided Deep Inferior Epigastric Artery (DIEA) perforator mapping with or without mapping using Computer Tomography angiography (CTA) in women over 18 years undergoing 2021 unilateral or bilateral breast reconstruction with an abdominal free flap.
Participants underwent scheduled reconstruction of one or both breasts with a free flap transferred from the lower abdomen. If there is a comparison group: Researchers compared interventional groups - examined using preoperative CTA of the abdominal wall supplemented with an examination of the perforators using CDU (active comparator group), and examined exclusively by using the CDU (experimental group), to see the comparison of the accuracy and contribution of CDU-guided DIEA perforator mapping with CTA mapping.
Read more
The hypothesis is that CDU examination alone is not inferior to CTA examination supplemented with parameters that CTA does not show (flow velocity, vessel diameters), by measuring these parameters with CDU.
The main questions it aims to answer are:
- To evaluate the comparison of the accuracy of surgeon-conducted CDU perforator mapping in defining the significant/dominant perforators and their exact location [XY coordinates] with the accuracy of CTA mapping.
- To compare the time duration of the CDU examination was measured.
- To measure the Fat Necrosis of the flap [3 months postoperative ]
- To measure the Flap Loss [1-week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op].
Read the detailed description
A blinded, randomized, prospective clinical trial was performed involving women over 18 years undergoing 2021 unilateral or bilateral breast reconstruction with an abdominal free flap. The inclusion of the mapping of major perforators as a part of preoperative deep inferior epigastric perforator (DIEP) flap planning reduces the operating time and complication rate. According to recent meta-analyses computed tomographic angiography (CTA) brings the most advantages; however, only a few studies comprising colour Doppler ultrasonography (CDU) were included with several biases in addition. Especially, studies directly comparing CTA and CDU (surgeons conducted in one study only, in one case) are rare. Recently, CDU has seen significant advances in quality and imaging capabilities, and ultrasound devices are widely available.
Women were originally randomized 1:1 to the groups one of which will undergo only CDU perforator mapping (experimental group) and the other using CTA+CDU (active comparator group). Every patient included in the CTA+CDU group preoperatively underwent CT angiography of the abdominal wall. Based on the CTA examination XY coordinates of DIEA perforators with a vessel calibre of 1 mm were determined.
The velocity and vessel diameters of these perforators were additionally examined using a CDU device. Any additional perforators were marked, nor were CTA deducted XY coordinates of marked perforators changed, based on the CDU examination. The same sonography surgeon performed all CDU examinations.
All patients included in the CDU group were examined with the same CDU device by the same sonography surgeon as patients included in CTA + CDU group. During the examination, DIEA perforators were mapped and those with a vessel calibre of 1 mm were marked and XY coordinates deducted. Calibres and velocities of perforator vessels and the abdominal subcutaneous tissue thickness were measured.
In the CTA+CDU group, CDU was used only to determine the additional parameters necessary to define categories 1-3 (according to the number of perforators). Based on CDU, coordinates were not measured in the CTA+CDU group. The main aim of this clinical study is to compare the accuracy of perforator localization (coordinates) using CDU vs. CTA.
Based on the preoperative mapping, all patients in both groups were assigned a category for each flap as follows:
- At least one perforator of the flap meets the criteria defined for a dominant perforator. In such a case, the tactic was to dissect a single perforator flap.
- Any perforator meets the criteria defined for a dominant perforator, but at least two perforators on the same DIEA branch meet the criteria for a significant perforator. In such a case, the tactic was to dissect the flap with the pedicle of two of those perforators.
- Any perforator meets the criteria defined for a dominant perforator or significant perforator. In such a case, the surgical tactic was to dissect the flap with a pedicle of three perforators or as an MS-TRAM flap.
The operating surgeon was fully informed of the results of the preoperative examination and the recommended perforator or perforator selected for the flap's pedicle. However, these recommendations were not binding, and the surgeon chose the tactics of the operation taking into consideration his clinical experience. Participating in the project did not change the surgical technique and the surgery was performed as standard according to current knowledge of medicine and common practice of the department. The surgery itself was not the subject of the research. XY coordinates and diameters of the dissected perforators were measured during the surgery.
R 4.1.3 software and Joinpoint Regression 4.9.0.0. were used to perform data management and exploratory statistical analysis (p = 0.05). A two-sided Wilcoxon test was used for verification of both patient groups' comparability. The same test was used to compare the length of the CDU examination in both groups. The breaking point on the curve showing the length of the CDU examination depending on the numerical order of the examined patient was searched using the Joinpoint Regression as a secondary outcome. Euclidean distance was used to determine the difference between the CDU/CTA and during the surgery measured coordinates of the dissected perforators. Statistical testing of the difference between the accuracy of CTA and CDU examinations was performed using the GLS method. The GEE model was used to determine the difference between the CDU/CTA+CDU recommended and finally dissected a number of perforators supplying the flap.
- Conditions
- Mammaplasty
- Being tested
- Colour Doppler Ultrasound
- Keywords
- CT Angiography, Mammaplasty, Ultrasonography, Doppler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colour Doppler UltrasoundProcedure or surgery
Also called CDU
The main perforators were examined using a LOGIQ S8/V1 CDU device (GE Healthcare, Chalfont St Giles, Great Britain) with a linear transducer of frequency 4-11 MHz. Measured parameters were: 1) calibre of artery and vein; 2) Peak systolic velocity (PSV) of blood in the artery [cm/s]; 3) blood velocity in the perforator vein [cm/s]; 2) the thickness of the subcutaneous tissue of the lower abdomen measured 4 cm caudal and lateral to the umbilicus. Any additional perforators were marked nor have CTA deducted XY coordinates of marked perforators changed based on the CDU examination. The same sonography surgeon performed all CDU examinations. The time duration of the CDU examination was measured.
| Study group | Role | What they receive |
|---|---|---|
| The CTA+CDU Group | No intervention | Every patient included in the CTA+CDU group preoperatively underwent CT angiography of the abdominal wall. Based on the CTA examination XY coordinates of DIEA perforators localized within the area between 2 cm cranial and 10 cm caudal from the umbilicus and with a vessel calibre of more than 1 mm were determined. The day before the surgery, the main perforators were marked on the patient's abdomen according to the coordinates deducted from the CTA. These perforators were additionally examined using a LOGIQ S8/V1 CDU device with a linear transducer of frequency 4-11 MHz. Any additional perforators were marked nor have CTA deducted XY coordinates of marked perforators changed based on the CDU examination. The same sonography surgeon performed all CDU examinations. The time duration of the CDU examination was measured. |
| The CDU Group | Experimental | All patients included in the CDU group were examined a day before the surgery with the same CDU device by the same sonography surgeon as patients included in CTA + CDU group. During the examination, DIEA perforators were mapped and the following parameters were monitored: 1) XY coordinates of DIEA perforators localized within the area between 2 cm cranial and 10 cm caudal from the umbilicus and with a vessel calibre of more than 1 mm; 2) calibres of perforator arteries and veins; 3) PSV in the perforator artery [cm/s]; 4) velocity in the perforator vein [cm/s]; 5) the thickness of the subcutaneous tissue of the lower abdomen measured 4 cm caudal and lateral to the umbilicus. The time duration of the CDU examination was measured. Receives: Procedure: Colour Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average deviations (Δ) in localization of perforators in each of the groups [cm]
In CDU group ΔCDU calculated for each dissected perforator as the Euclidean distance between (before the surgery, using CDU) mapped XY coordinates and the reference XY coordinates measured during the surgery. XY[0;0]=umbilicus
In CTA+CDU group ΔCTU (because XY coordinates in this group are deducted only based on CTA, CDU in this group is used only as an additional modality to help predict the dissection category A, B, C not to deduct XY coordinates) calculated for each dissected perforator as the Euclidean distance between (before the surgery, using CTA) mapped XY coordinates and the reference XY coordinates measured during the surgery. XY[0;0]=umbilicus
Measured: Through study completion, an average of 1 year
The success rate in estimating proper dissecting strategy [%]
In what percentage of cases the finally dissected flap category (A, B, C) is the same as the category estimated before the surgery based on CDU or CTA+CDU mapping.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
The time duration of the CDU examination.
The time duration of the CDU examination was measured.
Measured: 3 months post-operative
Fat Necrosis of the flap
Detected using clinical examination. Assessment for fat necrosis took place 3 months postoperatively by another plastic surgeon who was therefore blinded to the mapping method.
Measured: 3 months post-operative
Flap Loss
Partial flap loss defined as tissue loss greater than 5 percent of the flap or clinically manifested fat necrosis. Total flap loss was also assessed. These assessments were done during regular follow-up appointments with the care team.
Measured: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammaplastyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization was carried out using an envelope method, during which the patients were randomly assigned in a ratio 1:1 to an active comparator group: "CTA+CDU (preoperative examination of vascular anatomy by CTA supplemented with vessel calibre examination of the perforator using CDU)" or an experimental group: "CDU (preoperative examination of vascular anatomy by colour duplex sonography only)".
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anne's University Hospital Brno, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Sponsor
- Investigators
- Libor Streit, MD, PhD., Principal investigator, St. Anne's University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687006
- Sponsor's protocol ID
- CDU2021
- Acronym
- CDUxCTA
- Status last verified
- Jan 2023
- First submitted
- 29 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Deep Inferior Epigastric Artery Perforator Mapping - Color Doppler Ultrasound Versus CT Angiography: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05687006
- Acronym / sponsor ID
- CDUxCTA / CDU2021
- Conditions
- Mammaplasty
- Keywords
- CT Angiography, Mammaplasty, Ultrasonography, Doppler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Anne's University Hospital Brno, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Jan 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.
The goal of this clinical trial is to compare the accuracy and contribution of Color Doppler Ultrasound (CDU) guided Deep Inferior Epigastric Artery (DIEA) perforator mapping with or without mapping using Computer Tomography angiography (CTA) in women over 18 years undergoing 2021 unilateral or bilateral breast reconstruction with an abdominal free flap.
Participants underwent scheduled reconstruction of one or both breasts with a free flap transferred from the lower abdomen. If there is a comparison group: Researchers compared interventional groups - examined using preoperative CTA of the abdominal wall supplemented with an examination of the perforators using CDU (active comparator group), and examined exclusively by using the CDU (experimental group), to see the comparison of the accuracy and contribution of CDU-guided DIEA perforator mapping with CTA mapping.
The hypothesis is that CDU examination alone is not inferior to CTA examination supplemented with parameters that CTA does not show (flow velocity, vessel diameters), by measuring these parameters with CDU.
The main questions it aims to answer are:
- To evaluate the comparison of the accuracy of surgeon-conducted CDU perforator mapping in defining the significant/dominant perforators and their exact location [XY coordinates] with the accuracy of CTA mapping.
- To compare the time duration of the CDU examination was measured.
- To measure the Fat Necrosis of the flap [3 months postoperative ]
- To measure the Flap Loss [1-week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op].
Detailed description
A blinded, randomized, prospective clinical trial was performed involving women over 18 years undergoing 2021 unilateral or bilateral breast reconstruction with an abdominal free flap. The inclusion of the mapping of major perforators as a part of preoperative deep inferior epigastric perforator (DIEP) flap planning reduces the operating time and complication rate. According to recent meta-analyses computed tomographic angiography (CTA) brings the most advantages; however, only a few studies comprising colour Doppler ultrasonography (CDU) were included with several biases in addition. Especially, studies directly comparing CTA and CDU (surgeons conducted in one study only, in one case) are rare. Recently, CDU has seen significant advances in quality and imaging capabilities, and ultrasound devices are widely available.
Women were originally randomized 1:1 to the groups one of which will undergo only CDU perforator mapping (experimental group) and the other using CTA+CDU (active comparator group). Every patient included in the CTA+CDU group preoperatively underwent CT angiography of the abdominal wall. Based on the CTA examination XY coordinates of DIEA perforators with a vessel calibre of 1 mm were determined.
The velocity and vessel diameters of these perforators were additionally examined using a CDU device. Any additional perforators were marked, nor were CTA deducted XY coordinates of marked perforators changed, based on the CDU examination. The same sonography surgeon performed all CDU examinations.
All patients included in the CDU group were examined with the same CDU device by the same sonography surgeon as patients included in CTA + CDU group. During the examination, DIEA perforators were mapped and those with a vessel calibre of 1 mm were marked and XY coordinates deducted. Calibres and velocities of perforator vessels and the abdominal subcutaneous tissue thickness were measured.
In the CTA+CDU group, CDU was used only to determine the additional parameters necessary to define categories 1-3 (according to the number of perforators). Based on CDU, coordinates were not measured in the CTA+CDU group. The main aim of this clinical study is to compare the accuracy of perforator localization (coordinates) using CDU vs. CTA.
Based on the preoperative mapping, all patients in both groups were assigned a category for each flap as follows:
- At least one perforator of the flap meets the criteria defined for a dominant perforator. In such a case, the tactic was to dissect a single perforator flap.
- Any perforator meets the criteria defined for a dominant perforator, but at least two perforators on the same DIEA branch meet the criteria for a significant perforator. In such a case, the tactic was to dissect the flap with the pedicle of two of those perforators.
- Any perforator meets the criteria defined for a dominant perforator or significant perforator. In such a case, the surgical tactic was to dissect the flap with a pedicle of three perforators or as an MS-TRAM flap.
The operating surgeon was fully informed of the results of the preoperative examination and the recommended perforator or perforator selected for the flap's pedicle. However, these recommendations were not binding, and the surgeon chose the tactics of the operation taking into consideration his clinical experience. Participating in the project did not change the surgical technique and the surgery was performed as standard according to current knowledge of medicine and common practice of the department. The surgery itself was not the subject of the research. XY coordinates and diameters of the dissected perforators were measured during the surgery.
R 4.1.3 software and Joinpoint Regression 4.9.0.0. were used to perform data management and exploratory statistical analysis (p = 0.05). A two-sided Wilcoxon test was used for verification of both patient groups' comparability. The same test was used to compare the length of the CDU examination in both groups. The breaking point on the curve showing the length of the CDU examination depending on the numerical order of the examined patient was searched using the Joinpoint Regression as a secondary outcome. Euclidean distance was used to determine the difference between the CDU/CTA and during the surgery measured coordinates of the dissected perforators. Statistical testing of the difference between the accuracy of CTA and CDU examinations was performed using the GLS method. The GEE model was used to determine the difference between the CDU/CTA+CDU recommended and finally dissected a number of perforators supplying the flap.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization was carried out using an envelope method, during which the patients were randomly assigned in a ratio 1:1 to an active comparator group: "CTA+CDU (preoperative examination of vascular anatomy by CTA supplemented with vessel calibre examination of the perforator using CDU)" or an experimental group: "CDU (preoperative examination of vascular anatomy by colour duplex sonography only)".
| Arm | Type | Receives |
|---|---|---|
| The CTA+CDU Group | No intervention | –Every patient included in the CTA+CDU group preoperatively underwent CT angiography of the abdominal wall. Based on the CTA examination XY coordinates of DIEA perforators localized within the area between 2 cm cranial and 10 cm caudal from the umbilicus and with a vessel calibre of more than 1 mm were determined. The day before the surgery, the main perforators were marked on the patient's abdomen according to the coordinates deducted from the CTA. These perforators were additionally examined using a LOGIQ S8/V1 CDU device with a linear transducer of frequency 4-11 MHz. Any additional perforators were marked nor have CTA deducted XY coordinates of marked perforators changed based on the CDU examination. The same sonography surgeon performed all CDU examinations. The time duration of the CDU examination was measured. |
| The CDU Group | Experimental | Procedure: Colour Doppler UltrasoundAll patients included in the CDU group were examined a day before the surgery with the same CDU device by the same sonography surgeon as patients included in CTA + CDU group. During the examination, DIEA perforators were mapped and the following parameters were monitored: 1) XY coordinates of DIEA perforators localized within the area between 2 cm cranial and 10 cm caudal from the umbilicus and with a vessel calibre of more than 1 mm; 2) calibres of perforator arteries and veins; 3) PSV in the perforator artery [cm/s]; 4) velocity in the perforator vein [cm/s]; 5) the thickness of the subcutaneous tissue of the lower abdomen measured 4 cm caudal and lateral to the umbilicus. The time duration of the CDU examination was measured. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female;
- aged 18 to 65 years;
- undergoing uni- or bilateral breast free flap reconstruction harvested from the lower abdomen;
- signed informed consent to participate in the study.
Key exclusion criteria (7 listed)
- history of allergy to iodinated contrast material;
- history of abdominoplasty;
- Body Mass index > 35;
- active oncological disease ;
- Karnofsky Performance Status < 50;
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 |
|---|---|---|
| Colour Doppler UltrasoundAlso: CDUThe main perforators were examined using a LOGIQ S8/V1 CDU device (GE Healthcare, Chalfont St Giles, Great Britain) with a linear transducer of frequency 4-11 MHz. Measured parameters were: 1) calibre of artery and vein; 2) Peak systolic velocity (PSV) of blood in the artery [cm/s]; 3) blood velocity in the perforator vein [cm/s]; 2) the thickness of the subcutaneous tissue of the lower abdomen measured 4 cm caudal and lateral to the umbilicus. Any additional perforators were marked nor have CTA deducted XY coordinates of marked perforators changed based on the CDU examination. The same sonography surgeon performed all CDU examinations. The time duration of the CDU examination was measured. | Procedure or surgery | The CDU Group |
Primary outcome
The average deviations (Δ) in localization of perforators in each of the groups [cm]
Time frame: Through study completion, an average of 1 year
In CDU group ΔCDU calculated for each dissected perforator as the Euclidean distance between (before the surgery, using CDU) mapped XY coordinates and the reference XY coordinates measured during the surgery. XY[0;0]=umbilicus In CTA+CDU group ΔCTU (because XY coordinates in this group are deducted only based on CTA, CDU in this group is used only as an additional modality to help predict the dissection category A, B, C not to deduct XY coordinates) calculated for each dissected perforator as the Euclidean distance between (before the surgery, using CTA) mapped XY coordinates and the reference XY coordinates measured during the surgery. XY[0;0]=umbilicus
The success rate in estimating proper dissecting strategy [%]
Time frame: Through study completion, an average of 1 year
In what percentage of cases the finally dissected flap category (A, B, C) is the same as the category estimated before the surgery based on CDU or CTA+CDU mapping.
3 secondary outcomes
The time duration of the CDU examination.
Time frame: 3 months post-operative
Fat Necrosis of the flap
Time frame: 3 months post-operative
Flap Loss
Time frame: 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op
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 17 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Libor Streit, MD, PhD. principal investigator
St. Anne's University Hospital Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colour Doppler Ultrasound in people with Mammaplasty, run by St. Anne's University Hospital Brno, Czech Republic at 1 site in Czechia.
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 4 inclusion and 7 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 17 Jan 2023. 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 Czechia. 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?
The average deviations (Δ) in localization of perforators in each of the groups [cm] (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 17 Jan 2023.