Recipient Site Pre-conditioning in Fat Grafting

Condition Clinical Trial

— me15Schaefer  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03393598
• Other study ID #: ch15Schaefer
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Dirk J Schaefer, Prof MD
• Phone: ++41 61 265
• Email: dirk.schaefer[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Condition
• Graft Loss

Intervention

Device:
• pre-expansion using Kiwi® VAC-6000M.
The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM.
• pre-heating using Hilotherm Calido®.
The pre-heating will be performed with Hilotherm Calido®.
• pre-expansion-heating
Both preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied.

Locations

Country	Name	City	State
Switzerland	University Hospital Switzerland, Dept. of plastic, reconstructive, aestetic and hand surgery	Basel
Switzerland	Klinik Hirslanden, Plastic Surgery Group AG	Zuerich

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clinical Trial Unit, University Hospital Basel, Switzerland, Ospedale Regionale di Lugano

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat-graft survival volume	percent remaining	24 (+/-2) weeks after surgery
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)