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Completed

NCT Number: NCT03393598

Recipient Site Pre-conditioning in Fat Grafting

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

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Key information

Conditions

Graft Loss Condition Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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-heating

Device

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

Primary outcomes

  1. Fat-graft survival volume

    Time frame: 24 (+/-2) weeks after surgery

    percent remaining

Secondary outcomes

  1. 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).

  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).

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

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

Registry information

Official study title

Randomized Multi-centered Study on Enhancement of Autologous Fat Graft Survival by Recipient Site Preparation

Acronym: me15Schaefer

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2018
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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