Recipient Site Pre-conditioning in Fat Grafting

NCT03393598 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-12

No results posted yet for this study

Summary

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

Conditions

  • Graft Loss
  • Condition

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.

Sponsors & Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

    collaborator OTHER
  • Ospedale Regionale di Lugano

    collaborator OTHER
  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Dirk J Schaefer, Prof MD · Plastic, Reconstructive, Aesthetic, and Hand Surgery,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-08
Primary Completion
2024-04-11
Completion
2024-04-11

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03393598 on ClinicalTrials.gov