Recipient Site Pre-conditioning in Fat Grafting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2024-04-11

Brief Summary

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

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Detailed Description

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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.

Conditions

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Graft Loss Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

pre-expansion using Kiwi® VAC-6000M.

Intervention Type DEVICE

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

pre-expansion-heating

Intervention Type DEVICE

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

pre-heating using Hilotherm Calido®.

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

Group Type EXPERIMENTAL

pre-heating using Hilotherm Calido®.

Intervention Type DEVICE

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

pre-expansion-heating

Intervention Type DEVICE

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

pre-expansion-heating

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

Group Type EXPERIMENTAL

pre-expansion using Kiwi® VAC-6000M.

Intervention Type DEVICE

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

pre-heating using Hilotherm Calido®.

Intervention Type DEVICE

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

Control

No preconditioning methods will be applied.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pre-expansion using Kiwi® VAC-6000M.

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

Intervention Type DEVICE

pre-heating using Hilotherm Calido®.

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

Intervention Type DEVICE

pre-expansion-heating

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No