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| Name | Class |
|---|---|
| Clinical Trial Unit, University Hospital Basel, Switzerland | OTHER |
| Ospedale Regionale di Lugano | OTHER |
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This study aims to investigate the preparation of the recipient site prior to autologous fat grafting (AFG) using different methods.
Autologous fat grafting is emerging as a powerful tool for soft tissue reconstruction and augmentation and is widely used in plastic surgery. However, there is great variability in terms of long-term graft retention (survival). Moreover, the recipient site preparation is the phase of the procedure which received less attention in clinical and pre-clinical investigations. To provide information regarding an effective preparation of the recipient site may potentially lead to improvements in fat graft survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pre-expansion using Kiwi® VAC-6000M | Experimental | Expansion will be performed using a complete vacuum delivery system called Kiwi® VAC-6000M with the PalmPumpTM (Clinical Innovations, South Murray, Utah, USA). |
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| pre-heating using Hilotherm Calido®. | Experimental | Pre-Heating will be preformed using a Hiloterm Calido® System. |
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| pre-expansion-heating | Experimental | Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied. |
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| Control | No Intervention | No preconditioning methods will be applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pre-expansion using Kiwi® VAC-6000M. | Device | The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fat-graft survival volume | percent remaining | 24 (+/-2) weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| POSAS (Patient and Observer Scar Assesment Scale) | POSAS includes 2 subscales: Patient Scale and Observer Scale. Both subscales comprise six items scored numerically from 1 to 10. The sum of the two subscales provides the Total Score of the Patient and Observer Scale (minimum score 12, best scar conditions; maximum score 120, worse scar conditions). | day 7 (+/-3), week 12 (+/-2), week 24 (+/-2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk J Schaefer, Prof MD | Plastic, Reconstructive, Aesthetic, and Hand Surgery, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Switzerland, Dept. of plastic, reconstructive, aestetic and hand surgery | Basel | 4031 | Switzerland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41389580 | Derived | Speck NE, Ciftci U, Speck NM, Oranges CM, Popp A, Allen R, Menzi N, Kappos EA, Haug MD, Farhadi J, Schaefer DJ. Is there an ideal recipient site preconditioning to improve autologous fat graft retention in breast surgery? A prospective multi-center randomized controlled trial. J Plast Reconstr Aesthet Surg. 2026 Feb;113:435-444. doi: 10.1016/j.bjps.2025.11.044. Epub 2025 Nov 21. |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| pre-heating using Hilotherm Calido®. | Device | The pre-heating will be performed with Hilotherm Calido®. |
|
| pre-expansion-heating | Device | Both preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied. |
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| Occurence of Site infection | An infection of the surgical site according to CDC (Centers for Disease Control and Prevention) has been observed or not observed (yes or no). | day 7 (+/-3), week 12 (+/-2), week 24 (+/-2) |
| Surgical complication rate | According to the Dindo-Clavien classification from grade I (any deviation from the normal postoperative course without the need for pharmacological treatment, or surgical endoscopic and radiological intervention) to grade V (death of a patient). | day 7 (+/-3), week 12 (+/-2), week 24 (+/-2) |
| Pain assessed by VAS (Visual Analogue Scale) | Patient pain is assessed with VAS (Visual Analogue Scale for Pain) ranging from 0 (no pain) to 10 (worst imaginable pain). | day 7 (+/-3), week 12 (+/-2), week 24 (+/-2) |
| Klinik Hirslanden, Plastic Surgery Group AG |
| Zurich |
| Switzerland |