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

Not Applicable

Completed

• Conditions: Skin Laxity; Gastrostomy
• Interventions: Other: topical firming creams; Device: High intensity focused ultrasound

• Registration Number: NCT05994079
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2022-06-20
• Primary Completion: 2022-11-20
• Study Completion: 2022-12-20
• Status Verified: 2023-08
• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-15
• Last Update Submitted: 2023-08-15
• Study First Posted: 2023-08-16
• Last Update Posted: 2023-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medical topical firming creams group	topical firming creams	This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive medical topical firming creams.
high intensity focused ultrasound group	High intensity focused ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Assessment the change in abdominal skin laxity	at baseline and after 4 weeks of intervention	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).
Assessment othe change in skin laxity	at baseline and after 4 weeks of intervention	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.

Trial Locations

Locations (1)

Outpatient clinic faculty of physical therapy cairo university; 🇪🇬 Dokki, Egypt