Arm AestheticsNCT06427759
Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements
A study testing arm aesthetic surgery in people with Arm Aesthetics, run by Abdelrahman Mostafa Shehata Mohammed at 1 site in Egypt.
Trial summary
Brachioplasty is a popular plastic surgery procedure. Current and common various techniques are based on either surgeon 's sense preoperatively. A method is needed to define how much skin and soft tissue should be excised precisely, or what can be a reference point to design a brachioplasty mathematically.(1)… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Arm Aesthetics
- What is being tested?
- arm aesthetic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Jun 2026
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- group A : Anthropometric databases and studies done on females with normal BMI, In reproductive period , No history of pregnancy or weight fluctuation , No medical comorbidities .
- group B :Include patients asking for arm aesthetic surgery .
- Group B1: patients will be submitted for liposuction only.
- Group B2: patients will be submitted for liposuction and brachioplasty in same setting.
- Group B3: patients will be submitted for liposuction then brachioplasty after 3 months.
Who cannot join
- 1) Males 2) Athletes 3) Current morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Brachioplasty is a popular plastic surgery procedure. Current and common various techniques are based on either surgeon 's sense preoperatively. A method is needed to define how much skin and soft tissue should be excised precisely, or what can be a reference point to design a brachioplasty mathematically.(1)
Anthropometric reference measurements can be applied in designing arm aesthetic surgery.
Classically, anthropometry binds the upper arm length with forearm circumference and upper arm circumference to make postoperative results more harmonious and natural . (2)a 2020).
Read the detailed description
2.4.1- Type of the study: 2.4. 2- Study Setting: Plastic and Reconstructive Surgery Department, Assuit University Hospital 2.4. 3- Study subjects:
- Inclusion criteria:
- Group (A) this group will be available for measurements only with no interventions needed.
- Group (B) Include patients asking for arm aesthetic surgery .
- Group B1: patients will be submitted for liposuction only. liposuction is the preferred approach, particularly in young patients after massive weight loss.
- Group B2: patients will be submitted for liposuction and brachioplasty in same setting. When skin laxity is excessive, even in young patients, an extensive arm-long operation that extends across the axilla and onto the lateral chest is indicated.
- Group B3: patients will be submitted for liposuction then brachioplasty after 3 months. in borderline cases to take chance for skin retraction .
- Sample Size Calculation: sample size was calculated using g power program version 3.1.9.7 in order to detect anthropometric measures of arm and compare these measures with post operative cases, assumed effect size 0.8 based on clinical assumption (novel study) , α error 0.2 power 0.8 and allocation 1:1:1 the sample size will be 40 patients for each group. 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Group (A) will be subjected to these measures
*Arm length : Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle
*Arm circumference : upper arm circumference Mid arm Lower arm
- Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree. Group (B) will be subjected to
- Group B1: patients will be submitted for liposuction only.
- Group B2: patients will be submitted for liposuction and brachioplasty in the same setting.
- Group B3: patients will be submitted for liposuction then brachioplasty after 3, 6 and 12 months.
Pre-operative Assessment:
- Patient history.
- History of massive weight loss or any operation
- Preoperative investigations
- Informed consent.
- Pre-operative photography. operative technique :- 1- most patients will take general anaesthesia . 2- then sterilization with betadine solution . 3 - pt positioned in supine position . 4- patient will be subjected according to its group to group(A): after injection of tumescent fluids - waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4 . group(B): after injection of tumescent fluids in the medial part of arm only(excised part ) - waiting 15 minute - then excision of medial part according to pinch test . group (C): after injection of tumescent fluids all around _ waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4 . excision of the excessed part medially will be done after 3 months .
Patients will be subjected to arm measures before and after operation
- Arm length :
Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle
*Arm circumference : upper arm circumference Mid arm Lower arm
- Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree
- Pinch Test:
- Excess skin :
- Site of maximum redundancy:(Upper - Middle - Lower) arm
- Grade of Lipodystrophy:
Grade 1 :minimal fat with no ptosis Grade 2A :moderate fat with ptosis less than 5 cm Grade 2B : moderate to severe fat with ptosis 5- 10 cm Grade 3: extreme fat with ptosis more than 10 cm Grade 4 : mild to moderate fat with ptosis more than 10 cm. (3) Then comparing of post operative measurements after 3 , 6 and 12 months with the anthropometric measures of group (A) .
- Conditions
- Arm Aesthetics
- Being tested
- arm aesthetic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arm aesthetic surgeryProcedure or surgery
Also called liposuction, brachioplasty
liposuction of arms brachioplasty of arms
| Study group | Role | What they receive |
|---|---|---|
| anthropometric measures | No intervention | *Group (A) Inclusion criteria of study: Anthropometric databases and studies done on females with normal BMI, In reproductive period , No history of pregnancy or weight fluctuation , No medical comorbidities . |
| arm aesthetic surgery | Experimental | * Group (B) Include patients asking for arm aesthetic surgery .
* Group B1: patients will be submitted for liposuction of arms only.
* Group B2: patients will be submitted for liposuction and brachioplasty in same setting.
* Group B3: patients will be submitted for liposuction then brachioplasty after 3 months. Receives: Procedure: arm aesthetic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group(A) anthropometric measures of arm length , arm circumference and forearm circumference . Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A
Group(A) anthropometric measures of arm length , arm circumference and forearm circumference .
Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arm AestheticsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdelrahman Mostafa Shehata Mohammed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrahman Mostafa Shehata Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427759
- Sponsor's protocol ID
- 241094084
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements
- ClinicalTrials.gov ID
- NCT06427759
- Acronym / sponsor ID
- 241094084
- Conditions
- Arm Aesthetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Abdelrahman Mostafa Shehata MohammedUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 May 2024 (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.
Brachioplasty is a popular plastic surgery procedure. Current and common various techniques are based on either surgeon 's sense preoperatively. A method is needed to define how much skin and soft tissue should be excised precisely, or what can be a reference point to design a brachioplasty mathematically.(1)
Anthropometric reference measurements can be applied in designing arm aesthetic surgery.
Classically, anthropometry binds the upper arm length with forearm circumference and upper arm circumference to make postoperative results more harmonious and natural . (2)a 2020).
Detailed description
2.4.1- Type of the study: 2.4. 2- Study Setting: Plastic and Reconstructive Surgery Department, Assuit University Hospital 2.4. 3- Study subjects:
- Inclusion criteria:
- Group (A) this group will be available for measurements only with no interventions needed.
- Group (B) Include patients asking for arm aesthetic surgery .
- Group B1: patients will be submitted for liposuction only. liposuction is the preferred approach, particularly in young patients after massive weight loss.
- Group B2: patients will be submitted for liposuction and brachioplasty in same setting. When skin laxity is excessive, even in young patients, an extensive arm-long operation that extends across the axilla and onto the lateral chest is indicated.
- Group B3: patients will be submitted for liposuction then brachioplasty after 3 months. in borderline cases to take chance for skin retraction .
- Sample Size Calculation: sample size was calculated using g power program version 3.1.9.7 in order to detect anthropometric measures of arm and compare these measures with post operative cases, assumed effect size 0.8 based on clinical assumption (novel study) , α error 0.2 power 0.8 and allocation 1:1:1 the sample size will be 40 patients for each group. 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …): Group (A) will be subjected to these measures
*Arm length : Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle
*Arm circumference : upper arm circumference Mid arm Lower arm
- Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree. Group (B) will be subjected to
- Group B1: patients will be submitted for liposuction only.
- Group B2: patients will be submitted for liposuction and brachioplasty in the same setting.
- Group B3: patients will be submitted for liposuction then brachioplasty after 3, 6 and 12 months.
Pre-operative Assessment:
- Patient history.
- History of massive weight loss or any operation
- Preoperative investigations
- Informed consent.
- Pre-operative photography. operative technique :- 1- most patients will take general anaesthesia . 2- then sterilization with betadine solution . 3 - pt positioned in supine position . 4- patient will be subjected according to its group to group(A): after injection of tumescent fluids - waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4 . group(B): after injection of tumescent fluids in the medial part of arm only(excised part ) - waiting 15 minute - then excision of medial part according to pinch test . group (C): after injection of tumescent fluids all around _ waiting 15 minutes - liposuction will be done circumferential in arm with cannula 4 . excision of the excessed part medially will be done after 3 months .
Patients will be subjected to arm measures before and after operation
- Arm length :
Lateral length from acromion to lateral epicondyle Medial length from axilla to medial epicondyle
*Arm circumference : upper arm circumference Mid arm Lower arm
- Forearm circumference at widest point Arm assessed with elbow flexed at 90 degree and shoulder abducted at 90 degree
- Pinch Test:
- Excess skin :
- Site of maximum redundancy:(Upper - Middle - Lower) arm
- Grade of Lipodystrophy:
Grade 1 :minimal fat with no ptosis Grade 2A :moderate fat with ptosis less than 5 cm Grade 2B : moderate to severe fat with ptosis 5- 10 cm Grade 3: extreme fat with ptosis more than 10 cm Grade 4 : mild to moderate fat with ptosis more than 10 cm. (3) Then comparing of post operative measurements after 3 , 6 and 12 months with the anthropometric measures of group (A) .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements.
| Arm | Type | Receives |
|---|---|---|
| anthropometric measures | No intervention | –*Group (A) Inclusion criteria of study: Anthropometric databases and studies done on females with normal BMI, In reproductive period , No history of pregnancy or weight fluctuation , No medical comorbidities . |
| arm aesthetic surgery | Experimental | Procedure: arm aesthetic surgery* Group (B) Include patients asking for arm aesthetic surgery . * Group B1: patients will be submitted for liposuction of arms only. * Group B2: patients will be submitted for liposuction and brachioplasty in same setting. * Group B3: patients will be submitted for liposuction then brachioplasty after 3 months. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- group A : Anthropometric databases and studies done on females with normal BMI, In reproductive period , No history of pregnancy or weight fluctuation , No medical comorbidities .
- group B :Include patients asking for arm aesthetic surgery .
Key exclusion criteria (1 listed)
- 1) Males 2) Athletes 3) Current morbidities
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 |
|---|---|---|
| arm aesthetic surgeryAlso: liposuction, brachioplastyliposuction of arms brachioplasty of arms | Procedure or surgery | arm aesthetic surgery |
Primary outcome
Group(A) anthropometric measures of arm length , arm circumference and forearm circumference . Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A
Time frame: 3 years
Group(A) anthropometric measures of arm length , arm circumference and forearm circumference . Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- 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.
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 arm aesthetic surgery in people with Arm Aesthetics, run by Abdelrahman Mostafa Shehata Mohammed at 1 site in Egypt.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 May 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 Egypt. 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?
Results are not available in the source record.
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?
Group(A) anthropometric measures of arm length , arm circumference and forearm circumference . Group (B) compare postoperative measures of arm length , arm circumference and forearm circumference with anthropometric measures of Group A (time frame: 3 years). 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 24 May 2024.