Recipient Site Pre-conditioning in Fat Grafting

NCT03393598 | Completed

• 1 other identifier: ch15Schaefer
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Fat-graft survival volume

  percent remaining

  24 (+/-2) weeks after surgery

Secondary Outcomes (4)

• POSAS (Patient and Observer Scar Assesment Scale)

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

• Occurence of Site infection

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

• Surgical complication rate

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

• Pain assessed by VAS (Visual Analogue Scale)

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

Study Arms (4)

pre-expansion using Kiwi® VAC-6000M

EXPERIMENTAL

Expansion will be performed using a complete vacuum delivery system called Kiwi® VAC-6000M with the PalmPumpTM (Clinical Innovations, South Murray, Utah, USA).

Device: pre-expansion using Kiwi® VAC-6000M.; Device: pre-expansion-heating

pre-heating using Hilotherm Calido®.

EXPERIMENTAL

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

Device: pre-heating using Hilotherm Calido®.; Device: pre-expansion-heating

pre-expansion-heating

EXPERIMENTAL

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

Device: pre-expansion using Kiwi® VAC-6000M.; Device: pre-heating using Hilotherm Calido®.

Control

NO INTERVENTION

No preconditioning methods will be applied.

Interventions

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

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

pre-expansion using Kiwi® VAC-6000M; pre-expansion-heating

pre-heating using Hilotherm Calido®. DEVICE

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

pre-expansion-heating; pre-heating using Hilotherm Calido®.

pre-expansion-heating DEVICE

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

pre-expansion using Kiwi® VAC-6000M; pre-heating using Hilotherm Calido®.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Clinical Trial Unit, University Hospital Basel, Switzerland: collaborator
• Ospedale Regionale di Lugano: collaborator

Study Sites (2)

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

Basel, 4031, Switzerland

Location

Klinik Hirslanden, Plastic Surgery Group AG

Zurich, Switzerland

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk J Schaefer, Prof MD

  Plastic, Reconstructive, Aesthetic, and Hand Surgery,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: January 8, 2018
• Study Start: January 8, 2018
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

CH (2)