AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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.

Egypt1 site
  • Assiut University

    Asyut

Other trials in Egypt

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:

  1. 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 .
  1. 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:

  1. Patient history.
  2. History of massive weight loss or any operation
  3. Preoperative investigations
  4. Informed consent.
  5. 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 groups in NCT06427759
Study groupRoleWhat they receive
anthropometric measuresNo 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 surgeryExperimental* 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.

  1. 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.

  1. First posted24 May 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in