Graft Lossme15SchaeferNCT03393598
Recipient Site Pre-conditioning in Fat Grafting
A study testing pre-expansion using Kiwi® VAC-6000M., pre-heating using Hilotherm Calido®. and pre-expansion-heating in people with Graft Loss and Condition, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
This study aims to investigate the preparation of the recipient site prior to autologous fat grafting (AFG) using different methods. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Graft Loss, Condition
- What is being tested?
- pre-expansion using Kiwi® VAC-6000M., pre-heating using Hilotherm Calido®. and pre-expansion-heating
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 8 Jan 2018to 11 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Switzerland, Dept. of plastic, reconstructive, aestetic and hand surgery
Basel, 4031
Klinik Hirslanden, Plastic Surgery Group AG
Zurich
About this study
Official title: 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.
Read the 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.
- Conditions
- Graft Loss, Condition
- Being tested
- pre-expansion using Kiwi® VAC-6000M., pre-heating using Hilotherm Calido®., pre-expansion-heating
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Device: pre-expansion using Kiwi® VAC-6000M.; Device: pre-heating using Hilotherm Calido®. |
| Control | No intervention | No preconditioning methods will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat-graft survival volume
percent remaining
Measured: 24 (+/-2) weeks after surgery
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start8 Jan 2018
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland, Ospedale Regionale di Lugano
- Responsible party
- Sponsor
- Investigators
- Dirk J Schaefer, Prof MD, Principal investigator, Plastic, Reconstructive, Aesthetic, and Hand Surgery,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393598
- Sponsor's protocol ID
- ch15Schaefer
- Acronym
- me15Schaefer
- Status last verified
- Mar 2025
- First submitted
- 12 Dec 2017
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Speck NE, Ciftci U, Speck NM, Oranges CM, Popp A, Allen R, Menzi N, Kappos EA, Haug MD, Farhadi J, Schaefer DJ. Is there an ideal recipient site preconditioning to improve autologous fat graft retention in breast surgery? A prospective multi-center randomized controlled trial. J Plast Reconstr Aesthet Surg. 2026 Feb;113:435-444. doi: 10.1016/j.bjps.2025.11.044. Epub 2025 Nov 21.
PubMed 41389580
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multi-centered Study on Enhancement of Autologous Fat Graft Survival by Recipient Site Preparation
- ClinicalTrials.gov ID
- NCT03393598
- Acronym / sponsor ID
- me15Schaefer / ch15Schaefer
- Conditions
- Graft Loss, Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland, Ospedale Regionale di Lugano
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the preparation of the recipient site prior to autologous fat grafting (AFG) using different methods.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pre-expansion using Kiwi® VAC-6000M | Experimental | Device: pre-expansion using Kiwi® VAC-6000M., Device: pre-expansion-heatingExpansion will be performed using a complete vacuum delivery system called Kiwi® VAC-6000M with the PalmPumpTM (Clinical Innovations, South Murray, Utah, USA). |
| pre-heating using Hilotherm Calido®. | Experimental | Device: pre-heating using Hilotherm Calido®., Device: pre-expansion-heatingPre-Heating will be preformed using a Hiloterm Calido® System. |
| pre-expansion-heating | Experimental | Device: pre-expansion using Kiwi® VAC-6000M., Device: pre-heating using Hilotherm Calido®.Both preconditioning methods Hilotherm Calido® plus Kiwi® VAC-6000M- will be applied. |
| Control | No intervention | –No preconditioning methods will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-expansion using Kiwi® VAC-6000M.The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM. | Device | pre-expansion using Kiwi® VAC-6000M, pre-expansion-heating |
| pre-heating using Hilotherm Calido®.The pre-heating will be performed with Hilotherm Calido®. | Device | pre-expansion-heating, pre-heating using Hilotherm Calido®. |
| pre-expansion-heatingBoth preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied. | Device | pre-expansion using Kiwi® VAC-6000M, pre-heating using Hilotherm Calido®. |
Primary outcome
Fat-graft survival volume
Time frame: 24 (+/-2) weeks after surgery
percent remaining
4 secondary outcomes
POSAS (Patient and Observer Scar Assesment Scale)
Time frame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
Occurence of Site infection
Time frame: day 7 (+/-3), week 12 (+/-2), week 24 (+/-2)
Surgical complication rate
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 41389580Speck NE, Ciftci U, Speck NM, Oranges CM, Popp A, Allen R, Menzi N, Kappos EA, Haug MD, Farhadi J, Schaefer DJ. Is there an ideal recipient site preconditioning to improve autologous fat graft retention in breast surgery? A prospective multi-center randomized controlled trial. J Plast Reconstr Aesthet Surg. 2026 Feb;113:435-444. doi: 10.1016/j.bjps.2025.11.044. Epub 2025 Nov 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk J Schaefer, Prof MD principal investigator
Plastic, Reconstructive, Aesthetic, and Hand Surgery,
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-expansion using Kiwi® VAC-6000M., pre-heating using Hilotherm Calido®. and pre-expansion-heating in people with Graft Loss and Condition, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat-graft survival volume (time frame: 24 (+/-2) weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.