Recipient Site Pre-conditioning in Fat Grafting

University Hospital, Basel, Switzerland60 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Graft Loss Condition

Interventions

pre-expansion using Kiwi® VAC-6000M.DEVICE

The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM.

pre-heating using Hilotherm Calido®.DEVICE

The pre-heating will be performed with Hilotherm Calido®.

pre-expansion-heatingDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

University Hospital Switzerland, Dept. of plastic, reconstructive, aestetic and hand surgery

Basel, Switzerland

Klinik Hirslanden, Plastic Surgery Group AG

Zurich, Switzerland

Outcomes

Primary Outcomes

Fat-graft survival volume

percent remaining

Time frame: 24 (+/-2) weeks after surgery

Secondary Outcomes

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).

Time frame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)

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).

Time frame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)

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).

Time frame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)

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).

Time frame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)

Data from ClinicalTrials.gov

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