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

NCT05994079 | Completed DMC

• 1 other identifier: 012/003743
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Laxity; Gastrostomy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

high intensity focused ultrasound group

EXPERIMENTAL

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.

Device: High intensity focused ultrasound

medical topical firming creams group

ACTIVE COMPARATOR

This group includes 43 patients who have abdominal skin laxity post sleeve gastrectomy and who will receive medical topical firming creams.

Other: topical firming creams

Interventions

High intensity focused ultrasound DEVICE

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

high intensity focused ultrasound group

topical firming creams OTHER

medical topical firming creams

medical topical firming creams group

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic faculty of physical therapy cairo university

Dokki, Egypt

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Rania Elhawary

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: June 20, 2022
• Primary Completion: November 20, 2022
• Study Completion: December 20, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)