Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy

Skin Laxity Clinical Trial

Official title:

Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05994079
• Other study ID #: 012/003743
• Status: Completed
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 20, 2022
• Est. primary completion date: November 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cutis Laxa
• Gastrostomy
• Skin Laxity

Intervention

Device:
• High intensity focused ultrasound
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

Other:
• topical firming creams
medical topical firming creams

Locations

Country	Name	City	State
Egypt	Outpatient clinic faculty of physical therapy cairo university	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline and after 4 weeks of intervention
Primary	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).	at baseline and after 4 weeks of intervention