An interventional study of Hyaluronic Acid filler and Hyaluronic Acid filler in Atrophy, sponsored by Vandeputte, Joan, M.D.. Completed at 2 sites in Belgium. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-23.
Sponsored by Vandeputte, Joan, M.D. · Not applicable, Interventional, and Basic science
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.
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.
828 studies on the registry are indexed under Atrophy; 122 are open to participants now.
This study's enrollment of 5 is below the median of 34 across 603 interventional studies indexed under Atrophy.
Browse Atrophy studies →This is the only study on the registry with Vandeputte, Joan, M.D. as lead sponsor.
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Exclusion Criteria:
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
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
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.
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.
tissue inflammation after injection of hyaluronic acid filler
Presence of lymphocytes and/ or histiocytes around the filler through histologic examination \[Yes/No\]
Time frame: 3 weeks to 4 months after injection
tissue response after injection of hyaluronic acid filler
Presence of lymphocytes and/ or histiocytes and/ or macrophages around the filler through histologic examination \[Yes/No\]
Time frame: 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 \[Yes/No\]
Time frame: 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 \[Yes/No\]
Time frame: 1 week after injection
filler distribution in tissue
The height and width of the total filler spread \[mm\]
Time frame: 3 weeks to 4 months after injection
filler distribution in tissue
The height and width of the total filler spread \[mm\]
Time frame: 1 week after injection
Plan to share: Yes — pilot study on 5 patients: min, max, average measurements will be published
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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