Back to resultsEffect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy
Primary Purpose
Skin Laxity, Gastrostomy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High intensity focused ultrasound
topical firming creams
Sponsored by
About this trial
This is an interventional other trial for Skin Laxity
Eligibility Criteria
Inclusion Criteria: The subject selection will be according to the following criteria: Age range between 30-45 years. Female patients will participate in the study. All patients will have post sleeve gastrectomy abdominal skin laxity mild to moderate degree according to skin laxity scale Randomized images were evaluated by three clinical specialists for the degree of skin laxity (0-3 scale; 0 = no laxity, 1 = mild, 2 = moderate, 3 = severe). All patients enrolled to the study will have their informed consent. Exclusion Criteria: The potential participants will be excluded if they meet one of the following criteria: Age more than 45 years or less than 30 years. Patients have acute viral diseases, acute tuberculosis, mental disorders Older people with more extensive photo-aging, severe skin laxity. Open skin lesions at the target area. Severe or cystic acne. Metallic implants in the treatment area. Genetic disease Skin infectious diseases. Sociological diseases. Pregnant.
Sites / Locations
- Outpatient clinic faculty of physical therapy cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
high intensity focused ultrasound group
medical topical firming creams group
Arm Description
This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive high intensity focused ultrasound. patients will receive one session; time of session is 40 minutes.
This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive medical topical firming creams.
Outcomes
Primary Outcome Measures
Assessment othe change in skin laxity
By Investigator Global Aesthetic Improvement Scale (IGAIS).
The investigator will take clinical photographs using consistent patient positioning, camera settings (Canon EOS 600D, high-resolution setting, 5760 × 3840 pixels, Canon Inc., Tokyo, Japan), and room lighting.
Baseline and post-treatment photographs will randomly displayed, and evaluated by Investigator Global Aesthetic Improvement Scale (IGAIS) scores will be determined using side-by-side comparisons of pretreatment and post 4 weeks of treatment.
The scale ranges from 0 to 3 as 0 = No change, 1 = Mild improvement, 2 = Moderate improvement, 3 = Significant improvement.
Assessment the change in abdominal skin laxity
Assessment of abdominal skin laxity by the modified tissue tonometer :
Mark multiple points to be measured. Include an equivalent normal skin point(s).
Apply the MTT baseplate directly to the tissue through the holes in the template. Hold MTT vertically, with bubble of spirit level centered. Ensure no extra downward pressure is applied while resting the device on the tissue.
Record the depression of the plunger in millimeters after 6 seconds. The patient must be able to remain immobile when the MTT is in contact.
Repeat each point three times with at least 2 minutes' "rest" between attempts. Recalibrate the device to zero on a solid surface between each set of measures.
To determine longitudinal change in measures, comparison of averaged score for individual points is appropriate and/or analysis of the change of individual sagging points difference from normal skin control point(s).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05994079
Brief Title
Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy
Official Title
Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
November 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate the therapeutic effect of High intensity focused ultrasound in treatment of abdominal skin laxity post sleeve gastrectomy.
Detailed Description
Lax skin is a common consequence of bariatric weight loss, and it may require one or more plastic interventions.
This study carried out to investigate the effectiveness of High-intensity focused ultrasound (HIFU) in treatment of abdominal skin laxity post sleeve gastrectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Laxity, Gastrostomy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
high intensity focused ultrasound group
Arm Type
Experimental
Arm Description
This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive high intensity focused ultrasound. patients will receive one session; time of session is 40 minutes.
Arm Title
medical topical firming creams group
Arm Type
Active Comparator
Arm Description
This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive medical topical firming creams.
Intervention Type
Device
Intervention Name(s)
High intensity focused ultrasound
Intervention Description
Parameters:
Transducer frequency 7-2-mhz 1.5-9.0-mm focal depth. The pulse duration for each individual exposure ranged from 25 to 40 milliseconds.
Energy per ultrasound pulse ranged from 1.0 to 1.5 J
Intervention Type
Other
Intervention Name(s)
topical firming creams
Intervention Description
medical topical firming creams
Primary Outcome Measure Information:
Title
Assessment othe change in skin laxity
Description
By Investigator Global Aesthetic Improvement Scale (IGAIS).
The investigator will take clinical photographs using consistent patient positioning, camera settings (Canon EOS 600D, high-resolution setting, 5760 × 3840 pixels, Canon Inc., Tokyo, Japan), and room lighting.
Baseline and post-treatment photographs will randomly displayed, and evaluated by Investigator Global Aesthetic Improvement Scale (IGAIS) scores will be determined using side-by-side comparisons of pretreatment and post 4 weeks of treatment.
The scale ranges from 0 to 3 as 0 = No change, 1 = Mild improvement, 2 = Moderate improvement, 3 = Significant improvement.
Time Frame
at baseline and after 4 weeks of intervention
Title
Assessment the change in abdominal skin laxity
Description
Assessment of abdominal skin laxity by the modified tissue tonometer :
Mark multiple points to be measured. Include an equivalent normal skin point(s).
Apply the MTT baseplate directly to the tissue through the holes in the template. Hold MTT vertically, with bubble of spirit level centered. Ensure no extra downward pressure is applied while resting the device on the tissue.
Record the depression of the plunger in millimeters after 6 seconds. The patient must be able to remain immobile when the MTT is in contact.
Repeat each point three times with at least 2 minutes' "rest" between attempts. Recalibrate the device to zero on a solid surface between each set of measures.
To determine longitudinal change in measures, comparison of averaged score for individual points is appropriate and/or analysis of the change of individual sagging points difference from normal skin control point(s).
Time Frame
at baseline and after 4 weeks of intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The subject selection will be according to the following criteria:
Age range between 30-45 years.
Female patients will participate in the study.
All patients will have post sleeve gastrectomy abdominal skin laxity mild to moderate degree according to skin laxity scale Randomized images were evaluated by three clinical specialists for the degree of skin laxity (0-3 scale; 0 = no laxity, 1 = mild, 2 = moderate, 3 = severe).
All patients enrolled to the study will have their informed consent.
Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
Age more than 45 years or less than 30 years.
Patients have acute viral diseases, acute tuberculosis, mental disorders
Older people with more extensive photo-aging, severe skin laxity.
Open skin lesions at the target area.
Severe or cystic acne.
Metallic implants in the treatment area.
Genetic disease
Skin infectious diseases.
Sociological diseases.
Pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania Elhawary
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic faculty of physical therapy cairo university
City
Dokki
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy
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