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

Cairo University (CU)

Status: Completed

Conditions: Gastrostomy; Skin Laxity

Treatments: Device: High intensity focused ultrasound; Other: topical firming creams

Study type: Interventional

Funder types: Other

Identifiers

NCT05994079

012/003743

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: Female

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

high intensity focused ultrasound group

Experimental group

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.

Treatment:

Device: High intensity focused ultrasound

medical topical firming creams group

Active Comparator group

Description:

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

Treatment:

Other: topical firming creams