Recipient Site Pre-conditioning in Fat Grafting

Study Overview
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Brief Summary
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This study aims to investigate the preparation of the recipient site prior to autologous fat grafting (AFG) using different methods.

Detailed Description
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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.

Official Title
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Randomized Multi-centered Study on Enhancement of Autologous Fat Graft Survival by Recipient Site Preparation

Conditions
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Graft Loss, Condition

Intervention / Treatment
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* Device: pre-expansion using Kiwi® VAC-6000M.
* Device: pre-heating using Hilotherm Calido®.
* Device: pre-expansion-heating


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pre-expansion using Kiwi® VAC-6000M<br>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.<br>* The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM.<br>Device: pre-expansion-heating<br>* Both preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied.<br>|
| Experimental: pre-heating using Hilotherm Calido®.<br>Pre-Heating will be preformed using a Hiloterm Calido® System. | Device: pre-heating using Hilotherm Calido®.<br>* The pre-heating will be performed with Hilotherm Calido®.<br>Device: pre-expansion-heating<br>* Both preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied.<br>|
| Experimental: pre-expansion-heating<br>Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied. | Device: pre-expansion using Kiwi® VAC-6000M.<br>* The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM.<br>Device: pre-heating using Hilotherm Calido®.<br>* The pre-heating will be performed with Hilotherm Calido®.<br>|
| No Intervention: Control<br>No preconditioning methods will be applied. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat-graft survival volume | percent remaining | 24 (+/-2) weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |