- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03393598
Recipient Site Pre-conditioning in Fat Grafting (me15Schaefer)
February 26, 2024 updated by: University Hospital, Basel, Switzerland
Randomized Multi-centered Study on Enhancement of Autologous Fat Graft Survival by Recipient Site Preparation
This study aims to investigate the preparation of the recipient site prior to autologous fat grafting (AFG) using different methods.
Study Overview
Status
Recruiting
Conditions
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.
Study Type
Interventional
Enrollment (Estimated)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dirk J Schaefer, Prof MD
- Phone Number: 7301 ++41 61 265
- Email: dirk.schaefer@usb.ch
Study Contact Backup
- Name: Carlo Oranges, MD
- Phone Number: 86148 +41 61 32
- Email: carlo.oranges@usb.ch
Study Locations
-
-
-
Basel, Switzerland, 4031
- Recruiting
- University Hospital Switzerland, Dept. of plastic, reconstructive, aestetic and hand surgery
-
Contact:
- Dirk Schaefer, Prof MD
- Phone Number: 6148 +41 61 328
- Email: dirk.schaefer@usb.ch
-
Principal Investigator:
- Dirk Schaefer, Prof. Dr. med.
-
Zuerich, Switzerland
- Recruiting
- Klinik Hirslanden, Plastic Surgery Group AG
-
Contact:
- Jian Fahrhadi, Prof. Dr. med.
-
Principal Investigator:
- Jian Fahrhadi, Prof. Dr. med.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
|
The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM.
Both preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied.
|
Experimental: pre-heating using Hilotherm Calido®.
Pre-Heating will be preformed using a Hiloterm Calido® System.
|
Both preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied.
The pre-heating will be performed with Hilotherm Calido®.
|
Experimental: pre-expansion-heating
Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied.
|
The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM.
The pre-heating will be performed with Hilotherm Calido®.
|
No Intervention: Control
No preconditioning methods will be applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat-graft survival volume
Time Frame: 24 (+/-2) weeks after surgery
|
percent remaining
|
24 (+/-2) weeks after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
|
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).
|
day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
|
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).
|
day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
|
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).
|
day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dirk J Schaefer, Prof MD, Plastic, Reconstructive, Aesthetic, and Hand Surgery,
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2018
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
December 12, 2017
First Submitted That Met QC Criteria
January 2, 2018
First Posted (Actual)
January 8, 2018
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- ch15Schaefer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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