Recipient Site Pre-conditioning in Fat Grafting

Overview

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

Full Title of Study: “Randomized Multi-centered Study on Enhancement of Autologous Fat Graft Survival by Recipient Site Preparation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2025

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: 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).
  • Experimental: pre-heating using Hilotherm Calido®.
    • Pre-Heating will be preformed using a Hiloterm Calido® System.
  • Experimental: pre-expansion-heating
    • Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied.
  • No Intervention: Control
    • No preconditioning methods will be applied.

Clinical Trial Outcome Measures

Primary Measures

  • Fat-graft survival volume
    • Time Frame: 24 (+/-2) weeks after surgery
    • percent remaining

Secondary Measures

  • POSAS (Patient and Observer Scar Assesment Scale)
    • Time Frame: 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).
  • Occurence of Site infection
    • Time Frame: 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).
  • Surgical complication rate
    • Time Frame: 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)
    • Time Frame: 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).

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Basel, Switzerland
  • Collaborator
    • Clinical Trial Unit, University Hospital Basel, Switzerland
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dirk J Schaefer, Prof MD, Principal Investigator, Plastic, Reconstructive, Aesthetic, and Hand Surgery,
  • Overall Contact(s)
    • Dirk J Schaefer, Prof MD, ++41 61 265, dirk.schaefer@usb.ch

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