Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue

NCT ID: NCT02868749

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-22
• Study Completion Date: 2018-09-30

Brief Summary

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

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.

Conditions

Atrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Hyaluronic Acid filler 1 for deep injection

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

Group Type: EXPERIMENTAL

Hyaluronic Acid filler

Intervention Type: DEVICE

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.

Hyaluronic Acid filler

Intervention Type: DEVICE

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.

Hyaluronic Acid filler 2 for deep injection

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

Group Type: ACTIVE_COMPARATOR

Hyaluronic Acid filler

Intervention Type: DEVICE

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.

Hyaluronic Acid filler

Intervention Type: DEVICE

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.

Interventions

Hyaluronic Acid filler

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.

Intervention Type: DEVICE

Hyaluronic Acid filler

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

Vandeputte, Joan, M.D.

INDIV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joan H Vandeputte, MD

Role: PRINCIPAL_INVESTIGATOR

A.Z Oudenaarde (Oudenaarde General Hospital)

Locations

Universitair Ziekenhuis Brussel

Brussels, , Belgium

A.Z. Oudenaarde

Oudenaarde, , Belgium

Countries

Belgium

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Arlette JP, Trotter MJ. Anatomic location of hyaluronic acid filler material injected into nasolabial fold: a histologic study. Dermatol Surg. 2008 Jun;34 Suppl 1:S56-62; discussion S62-3. doi: 10.1111/j.1524-4725.2008.34244.x.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Rohrich RJ, Pessa JE. The fat compartments of the face: anatomy and clinical implications for cosmetic surgery. Plast Reconstr Surg. 2007 Jun;119(7):2219-2227. doi: 10.1097/01.prs.0000265403.66886.54.

Reference Type: BACKGROUND

PMID: 17519724 (View on PubMed)

Pilsl U, Rosmarin W, Anderhuber F. The premaxillary space: a location for filler injection? Dermatol Surg. 2014 Mar;40(3):301-4. doi: 10.1111/dsu.12431. Epub 2014 Jan 30.

Reference Type: BACKGROUND

PMID: 24479675 (View on PubMed)

Other Identifiers

BVL/JVL

Identifier Type: -

Identifier Source: org_study_id