Recipient Site Pre-conditioning in Fat Grafting

Not Applicable

Completed

• Conditions: Condition; Graft Loss
• Interventions: Device: pre-expansion using Kiwi® VAC-6000M.; Device: pre-expansion-heating; Device: pre-heating using Hilotherm Calido®.

• Registration Number: NCT03393598
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2018-01-02
• Study Start: 2018-01-08
• Study First Posted: 2018-01-08
• Primary Completion: 2024-04-11
• Study Completion: 2024-04-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pre-expansion using Kiwi® VAC-6000M	pre-expansion using Kiwi® VAC-6000M.	Expansion will be performed using a complete vacuum delivery system called Kiwi® VAC-6000M with the PalmPumpTM (Clinical Innovations, South Murray, Utah, USA).
pre-heating using Hilotherm Calido®.	pre-expansion-heating	Pre-Heating will be preformed using a Hiloterm Calido® System.
pre-expansion-heating	pre-expansion using Kiwi® VAC-6000M.	Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied.
pre-expansion using Kiwi® VAC-6000M	pre-expansion-heating	Expansion will be performed using a complete vacuum delivery system called Kiwi® VAC-6000M with the PalmPumpTM (Clinical Innovations, South Murray, Utah, USA).
pre-expansion-heating	pre-heating using Hilotherm Calido®.	Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied.
pre-heating using Hilotherm Calido®.	pre-heating using Hilotherm Calido®.	Pre-Heating will be preformed using a Hiloterm Calido® System.

Primary Outcome Measures

Name	Time	Method
Fat-graft survival volume	24 (+/-2) weeks after surgery	percent remaining

Secondary Outcome Measures

Name	Time	Method
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).
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).
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).

Trial Locations

Locations (2)

University Hospital Switzerland, Dept. of plastic, reconstructive, aestetic and hand surgery; 🇨🇭 Basel, Switzerland

Klinik Hirslanden, Plastic Surgery Group AG; 🇨🇭 Zuerich, Switzerland