Condition, Graft Loss
Conditions
Brief summary
This study aims to investigate the preparation of the recipient site prior to autologous fat grafting (AFG) using different methods.
Detailed description
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.
Interventions
DEVICEpre-expansion using Kiwi® VAC-6000M.
The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM.
DEVICEpre-heating using Hilotherm Calido®.
The pre-heating will be performed with Hilotherm Calido®.
DEVICEpre-expansion-heating
Both preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied.
Sponsors
Clinical Trial Unit, University Hospital Basel, Switzerland
Ospedale Regionale di Lugano
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Informed Consent as documented by signature * Patients presenting with contracted scars or body contouring deformities, especially as a result of previous radiation therapy or infection, in and around the breast. * Body mass index superior than 18.5
Exclusion criteria
* Need for antiplatelets drugs in the 5 days before surgery and 3 days after, * Known or suspected non-compliance, drug or alcohol abuse, * Inability to follow the procedures of the study due to language problems, psychological disorders, dementia of the participant, * Previous enrolment into the current study, * Enrolment of the investigator, his or her family members, employees and other dependent persons, * Patients with haemorrhagic diatheses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fat-graft survival volume | 24 (+/-2) weeks after surgery | percent remaining |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| POSAS (Patient and Observer Scar Assesment Scale) | day 7 (+/-3), week 12 (+/-2), week 24 (+/-2) | 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). |
| Occurence of Site infection | day 7 (+/-3), week 12 (+/-2), week 24 (+/-2) | An infection of the surgical site according to CDC (Centers for Disease Control and Prevention) has been observed or not observed (yes or no). |
| Surgical complication rate | day 7 (+/-3), week 12 (+/-2), week 24 (+/-2) | 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). |
| Pain assessed by VAS (Visual Analogue Scale) | day 7 (+/-3), week 12 (+/-2), week 24 (+/-2) | Patient pain is assessed with VAS (Visual Analogue Scale for Pain) ranging from 0 (no pain) to 10 (worst imaginable pain). |
Countries
Switzerland
Outcome results
None listed