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

NCT ID: NCT05994079

Last Updated: 2023-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2022-12-20

Brief Summary

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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

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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.

Conditions

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Skin Laxity Gastrostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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high intensity focused ultrasound group

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.

Group Type EXPERIMENTAL

High intensity focused ultrasound

Intervention Type 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

medical topical firming creams group

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

Group Type ACTIVE_COMPARATOR

topical firming creams

Intervention Type OTHER

medical topical firming creams

Interventions

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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

Intervention Type DEVICE

topical firming creams

medical topical firming creams

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Rania Hassan Kamel Abdelkader El-Hawary

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rania Elhawary

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Outpatient clinic faculty of physical therapy cairo university

Dokki, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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012/003743

Identifier Type: -

Identifier Source: org_study_id

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