Recipient Site Pre-conditioning in Fat Grafting (me15Schaefer)

University Hospital Basel

Status: Completed

Conditions: Condition; Graft Loss

Treatments: Device: pre-expansion-heating; Device: pre-heating using Hilotherm Calido®.; Device: pre-expansion using Kiwi® VAC-6000M.

Study type: Interventional

Funder types: Other

Identifiers

NCT03393598

ch15Schaefer

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 4 patient groups

pre-expansion using Kiwi® VAC-6000M

Experimental group

Description:

Expansion will be performed using a complete vacuum delivery system called Kiwi® VAC-6000M with the PalmPumpTM (Clinical Innovations, South Murray, Utah, USA).

Treatment:

Device: pre-expansion using Kiwi® VAC-6000M.

Device: pre-expansion-heating

pre-heating using Hilotherm Calido®.

Experimental group

Description:

Pre-Heating will be preformed using a Hiloterm Calido® System.

Treatment:

Device: pre-heating using Hilotherm Calido®.

Device: pre-expansion-heating

pre-expansion-heating

Experimental group

Description:

Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied.

Treatment:

Device: pre-expansion using Kiwi® VAC-6000M.

Device: pre-heating using Hilotherm Calido®.

Control

No Intervention group

Description:

No preconditioning methods will be applied.