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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment othe change in skin laxity | By Investigator Global Aesthetic Improvement Scale (IGAIS).
| 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 |
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Inclusion Criteria:
The subject selection will be according to the following criteria:
Exclusion Criteria:
The potential participants will be excluded if they meet one of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rania Elhawary | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient clinic faculty of physical therapy cairo university | Dokki | Egypt |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| topical firming creams | Other | medical topical firming creams |
|
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |