- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06427759
Optimizing Aesthetic Outcome for Arm Contouring Surgery by Utilizing Anthropometric Measurements
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).
Study Overview
Status
Conditions
Intervention / Treatment
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:
a. 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 .
c. 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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Assiut, Egypt
- Assiut University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 1) Males 2) Athletes 3) Current morbidities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: anthropometric measures
*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 .
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Experimental: arm aesthetic surgery
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liposuction of arms brachioplasty of arms
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 241094084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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