NCT02868749

Histology and Ultrasound Pilot Study of HA Gels Adipose Tissue

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Vandeputte, Joan, M.D. · Individual
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2017-03-22
• Primary completion: 2018-04-11
• Completion: 2018-09-30
• First posted: 2016-08-16
• Last updated: 2019-01-23

Locations

2 sites across 1 country: Belgium