## Protocol Section
### Identification Module
**NCT ID:** NCT05994079

**Brief Title:** Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy

**Official Title:** Effect Of High-Intensity Focused Ultrasound On Abdominal Skin Laxity Post Sleeve Gastrectomy

#### Organization Study ID Info
**ID:** 012/003743
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2022-12-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-16

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-11-20

**Type:** ACTUAL

#### Start Date
**Date:** 2022-06-20

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2023-08-16
**Type:** ACTUAL
**Study First Submit Date:** 2023-08-08
**Study First Submit QC Date:** 2023-08-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Rania Hassan Kamel Abdelkader El-Hawary

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Skin Laxity

- Gastrostomy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 86

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: High intensity focused ultrasound

**Label:** high intensity focused ultrasound group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: topical firming creams

**Label:** medical topical firming creams group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- high intensity focused ultrasound group

**Description:** 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

**Name:** High intensity focused ultrasound

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- medical topical firming creams group

**Description:** medical topical firming creams

**Name:** topical firming creams

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Assessment othe change in skin laxity

**Time Frame:** at baseline and after 4 weeks of intervention

**Description:** 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).

**Measure:** Assessment the change in abdominal skin laxity

**Time Frame:** at baseline and after 4 weeks of intervention

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 30 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Dokki

**Country:** Egypt

**Facility:** Outpatient clinic faculty of physical therapy cairo university

#### Overall Officials

**Official 1:**

**Affiliation:** Cairo University

**Name:** Rania Elhawary

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012873

- Term: Skin Diseases, Genetic

- ID: D000030342

- Term: Genetic Diseases, Inborn

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6692

- Name: Cutis Laxa

- Relevance: HIGH

- As Found: Skin Laxity

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15676

- Name: Skin Diseases, Genetic

- Relevance: LOW

- As Found: Unknown

- ID: M23686

- Name: Genetic Diseases, Inborn

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1692

- Name: Cutis Laxa

- Relevance: HIGH

- As Found: Skin Laxity

### Condition Browse Module - Meshes

- ID: D000003483

- Term: Cutis Laxa

### Misc Info Module

- Version Holder: 2024-05-24
