Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universitair Ziekenhuis Brussel | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic Acid filler 1 for deep injection | Experimental | 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 |
|
| Hyaluronic Acid filler 2 for deep injection | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic Acid filler | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joan H Vandeputte, MD | A.Z Oudenaarde (Oudenaarde General Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Brussels | B-1090 | Belgium | |||
| A.Z. Oudenaarde |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21272119 | Background | Flynn TC, Sarazin D, Bezzola A, Terrani C, Micheels P. Comparative histology of intradermal implantation of mono and biphasic hyaluronic acid fillers. Dermatol Surg. 2011 May;37(5):637-43. doi: 10.1111/j.1524-4725.2010.01852.x. Epub 2011 Jan 27. | |
| 16485276 | Background | Hirsch RJ, Narurkar V, Carruthers J. Management of injected hyaluronic acid induced Tyndall effects. Lasers Surg Med. 2006 Mar;38(3):202-4. doi: 10.1002/lsm.20283. |
Not provided
Not provided
pilot study on 5 patients: min, max, average measurements will be published
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hyaluronic Acid filler | 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. |
|
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 |
| Oudenaarde |
| B-9700 |
| Belgium |
| 18547183 | Background | 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. |
| 24077012 | Background | Micheels P, Sarazin D, Besse S, Sundaram H, Flynn TC. A blanching technique for intradermal injection of the hyaluronic acid Belotero. Plast Reconstr Surg. 2013 Oct;132(4 Suppl 2):59S-68S. doi: 10.1097/PRS.0b013e31829a02fb. |
| 26918965 | Background | Franca Wanick FB, Almeida Issa MC, Luiz RR, Soares Filho PJ, Olej B. Skin Remodeling Using Hyaluronic Acid Filler Injections in Photo-Aged Faces. Dermatol Surg. 2016 Mar;42(3):352-9. doi: 10.1097/DSS.0000000000000659. |
| 20048624 | Background | Shaw RB Jr, Katzel EB, Koltz PF, Kahn DM, Girotto JA, Langstein HN. Aging of the mandible and its aesthetic implications. Plast Reconstr Surg. 2010 Jan;125(1):332-342. doi: 10.1097/PRS.0b013e3181c2a685. |
| 17519724 | Background | 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. |
| 24479675 | Background | 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. |