NCT03393598

Recipient Site Pre-conditioning in Fat Grafting

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft Loss
• Condition

Interventions

Type	Name	Description
DEVICE	pre-expansion using Kiwi® VAC-6000M.	The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM.
DEVICE	pre-heating using Hilotherm Calido®.	The pre-heating will be performed with Hilotherm Calido®.
DEVICE	pre-expansion-heating	Both preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied.

Timeline

• Start date: 2018-01-08
• Primary completion: 2024-04-11
• Completion: 2024-04-11
• First posted: 2018-01-08
• Last updated: 2025-03-12

Locations

2 sites across 1 country: Switzerland