An interventional study of pre-expansion using Kiwi® VAC-6000M. and pre-heating using Hilotherm Calido®. in Graft Loss and Condition, sponsored by University Hospital, Basel, Switzerland. Completed at 2 sites in Switzerland. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Treatment
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.
University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Expansion will be performed using a complete vacuum delivery system called Kiwi® VAC-6000M with the PalmPumpTM (Clinical Innovations, South Murray, Utah, USA).
Device: pre-expansion using Kiwi® VAC-6000M. · Device: pre-expansion-heating
Pre-Heating will be preformed using a Hiloterm Calido® System.
Device: pre-heating using Hilotherm Calido®. · Device: pre-expansion-heating
Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied.
Device: pre-expansion using Kiwi® VAC-6000M. · Device: pre-heating using Hilotherm Calido®.
No preconditioning methods will be applied.
The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM.
The pre-heating will be performed with Hilotherm Calido®.
Both preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied.
Fat-graft survival volume
percent remaining
Time frame: 24 (+/-2) weeks after surgery
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).
Time frame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
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).
Time frame: 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).
Time frame: 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).
Time frame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
Ran from Jan 2018 to primary completion in Apr 2024, 75 months.
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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