Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue

Study Overview
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Brief Summary
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This study is a single-blind intra-individual comparative study to evaluate the short and medium term tissue response after the injection of 2 brands of hyaluronic acid gels (HA), designed for deep injection, that have been used for several years on a worldwide scale.

Detailed Description
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The study will be disclosed to patients who present with an indication for either abdominoplasty or bilateral breast reduction with a Wise pattern skin excision (inverted T inframammary scar) Informed consent will be obtained from volunteers at their next consultation, during which the preoperative preparation is finalised and the surgery is booked. Participants will receive injections for the first time three weeks to four months before the operation and for the second time five to nine days before the operation, in tissue that will be removed during the surgery. In each session, through one single access point, a linear retrograde, subcutaneous injection will be performed with 0,5 ml of each of the studied hyaluronic acid gels, each in an opposite direction, each parallel to the skin surface. Both sessions will be monitored by ultrasound examination. After the injections, the 2 cm of injected area which is most remote from the entrance point of the cannula will be remodelled by finger pressure and tissue pinching, to simulate remodelling as commonly performed after filler injection. At the beginning of the operation, the injected subcutaneous fat will be removed with the overlying skin, to be sent for histologic examination. The objective of the histologic examination is to assess the tissue response at one week versus three weeks to four months after the injection, as well as to assess the spread of the products, with and without remodelling after injection.

Official Title
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Comparative Clinical, Histological and Ultrasound Pilot Study of Two Hyaluronic Acid Gel Fillers, Designed for Deep Injection, in Adipose Tissue

Conditions
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Atrophy

Intervention / Treatment
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* Device: Hyaluronic Acid filler
* Device: Hyaluronic Acid filler


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients eligible for and requesting abdominoplasty patients eligible for and requesting bilateral breast reduction Exclusion Criteria: Patients prone to hypertrophic scarring or keloids Hypersensitivity to hyaluronic acid Hypersensitivity to lidocaine or amide type local anaesthetics Autoimmune disease Severe, multiple allergies or anaphylactic shock Epilepsy Heart rhythm disorders Porphyria, congenital methemoglobinemia, glucose-6 phosphate dehydrogenase deficiencies, treatment with methaemoglobin-inducing substances. Previous streptococcal disease (acute rheumatic fever whether or not with heart valve involvement) Patients on medication which slows hepatic metabolism (such as cimetidine, beta-blockers) Diabetes requiring insulin treatment Major system disease. Coagulation disorders. Anticoagulation therapy. Chronic use of acetylsalicylic acid. Previous surgery in the areas eligible for injections. All contraindications to their surgical treatment (such as pregnancy or lactation).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyaluronic Acid filler 1 for deep injection<br>Injection Session 1 of Hyaluronic Acid filler 1, 3 weeks to 4 months before the surgery Injection Session 2 of Hyaluronic Acid filler 1, 5 to 9 days before the surgery | Device: Hyaluronic Acid filler<br>* Linear retrograde, subcutaneous injection of 0,5 ml of hyaluronic acid gel in one side of the abdomen or one breast, 3 weeks to 4 months before the surgery.<br>Device: Hyaluronic Acid filler<br>* Linear retrograde, subcutaneous injection of 0,5 ml of hyaluronic acid gel in other side of the abdomen or other breast, 5 to 9 days before the surgery.<br>|
| Active Comparator: Hyaluronic Acid filler 2 for deep injection<br>Injection Session 1 of Hyaluronic Acid filler 2, 3 weeks to 4 months before the surgery Injection Session 2 of Hyaluronic Acid filler 2, 5 to 9 days before the surgery | Device: Hyaluronic Acid filler<br>* Linear retrograde, subcutaneous injection of 0,5 ml of hyaluronic acid gel in one side of the abdomen or one breast, 3 weeks to 4 months before the surgery.<br>Device: Hyaluronic Acid filler<br>* Linear retrograde, subcutaneous injection of 0,5 ml of hyaluronic acid gel in other side of the abdomen or other breast, 5 to 9 days before the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tissue inflammation after injection of hyaluronic acid filler | Presence of lymphocytes and/ or histiocytes around the filler through histologic examination [Yes/No] | 3 weeks to 4 months after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tissue response after injection of hyaluronic acid filler | Presence of lymphocytes and/ or histiocytes and/ or macrophages around the filler through histologic examination [Yes/No] | 1 week after injection | 
| tissue response after injection and remodelling of hyaluronic acid filler | Presence of lymphocytes and/ or histiocytes and/ or macrophages around the filler through histologic examination [Yes/No] | 3 weeks to 4 months after injection | 
| tissue response after injection and remodelling of hyaluronic acid filler | Presence of lymphocytes and/ or histiocytes and/ or macrophages around the filler through histologic examination [Yes/No] | 1 week after injection | 
| filler distribution in tissue | The height and width of the total filler spread [mm] | 3 weeks to 4 months after injection | 
| filler distribution in tissue | The height and width of the total filler spread [mm] | 1 week after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic Acid, histology, ultrasound, subcutaneous, adipose tissue