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Completed

NCT Number: NCT05994079

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

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.

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Key information

Conditions

Skin Laxity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Gastrostomy Genetic Diseases, Inborn Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

30 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic faculty of physical therapy cairo university

Dokki, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

topical firming creams

Other

medical topical firming creams

Primary outcomes

  1. Assessment othe change in skin laxity

    Time frame: 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.

  2. Assessment the change in abdominal skin laxity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2023
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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