Trial document





This trial has been registered retrospectively.
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  DRKS00004234

Trial Description

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Title

"De novo" breast reconstruction with autologuos fat grafting in post-mastectomy patients

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this multicenter -trial was carried out in 4 European institutions in the field of Plastic Surgery.
Patients were included after the loss of the breast due to history of brest cancer. A stepwise reconstruction of the breast with autologous lipotransfer (from the upper leg or abdominal region) was achieved after mean 4 to 6 interventions. Up to date there is poor literature aboout complete breast reconstruction with this method. The aim of the study was an establishement of a stardadized protocol in oncologic patients for breast reconstruction with this surgical technique.

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Brief Summary in Scientific Language

A retrospective multicenter trial (Germany, Finland, France, Italy) was performed in order to install a protcol for complete breast reconstruction with autologous fat grafting after total uni - or bilateral mastectomy. Inclusion criteria were fullfilled by 28 patients (32 breast). In total 113 interventions with 135 grafting procedure with water assistenting liposuction (BEAULI -Method) were carried out. During follow-up period only 2,9% liponecrosis, 0,74% granuloma and 0,74% infection were detected. No significant or unaspected side effects were detected. Patients were discharged the same day or stayed simply overnight for monitoring. High patients satifaction was determined with a 10-point-Linkert scale questionnaire. Aesthetic outcome was evaluated from two board listed blinded plastic surgeons. We observed an upward trend of this reconstruvtive technique, however few literature and experience in oncoplasty exists.

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Organizational Data

  •   DRKS00004234
  •   2012/07/06
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  •   yes
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Secondary IDs

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Health Condition or Problem studied

  •   C50.9 -  Malignant neoplasm: Breast, unspecified
  •   Post-mastectomy (uni- or bilateral) condition, scar contracture, scar fibrosis
  •   Z42.9 -  Follow-up care involving plastic surgery, unspecified
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Interventions/Observational Groups

  •   Free fat transfer with waterjet assisted liposuction for complete breast reconstruction after total mastectomy. On average 4 to 7 procedures were required, mean operation time 60min, additional operative techniques (like NAC reconstruction) were carried out simultaneously. Interval between procedures was at least 3 months. Follow - up after 6 months with clinical examination, foto documentary, control of the weight, questionnaire and radiological evaluation (mammography or sonograohy). Patients satisfaction was obtained by 10-point-Linkert scale. Aesthetic outcome was evaluated by 2 blinded board listed plastic suregeons on a 5-point- scale.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1) Complete breast reconstruction with autologous waterjet assisted lipotransfer : evaluation of the patient chart, duration of the reconstructive treatment, single procedure time, single and total fat volumes grafted, additional reconstructions

2) method's safety: at least 6 months follow-up, mammography or sonography,control of weight changes, foto documentary

3) patients satisfaction after completed breast reconstruction (at least 6 months): 10-point Linkert scale (3 questions) and optional comments.

4) Aesthetic results: 2 blinded board listed plastic surgeons used a 5-point ranking scale to evalute the digital fotos (pre and after)

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Secondary Outcome

Improvement of the scar : clinical examination during follow-up regarding texture, color, softness.

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Countries of Recruitment

  •   Germany
  •   Finland
  •   France
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/02/18
  •   50
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Non-smokers, BMI<30, history of invasive breast cancer and total mastectomy (uni - or bilateral), end of primary therapy (irradiation or chemotherapy) for at least 2 months befor reconstruction start, denial of conservative reconstruction methods (flap - or implant based), inclusion in at least 6 months follow-up period after accomplishment of reconstruction

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Exclusion Criteria

Comorbidities: diabetes, smoking, adipositas with BMI>30, wight changes >5kg pre and post treatment, prior flap-based reconstruction, breast saving mastectomy, partial mastectomy, implants in situ, incompleted reconstruction

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Addresses

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    • Park - Klinik Birkenwerder
    • Mr.  Dr.med.  Klaus  Ueberreiter 
    • Hubertusstraße 22
    • 16547  Birkenwerder
    • Germany
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    • Helsinki University Hospital Devision of Plastic and Reconstructive Surgery
    • Ms.  Prof. Dr.  Susanna  Kauhanen 
    • Topeliuksenkatu 5
    • HUS 00029  Helsinki
    • Finland
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    • Park - Klinik Birkenwerder Fachklinik für Plastische und Ästhetische Chirurgie
    • Ms.  Dr. med.  Delia Letizia  Hoppe 
    • Hubertusstraße 22
    • 16457  Birkenwerder
    • Germany
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    • Park - Klinik Birkenwerder
    • Mr.  Dr.med.  Klaus  Ueberreiter 
    • Hubertusstraße 22
    • 16547  Birkenwerder
    • Germany
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Sources of Monetary or Material Support

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    • Park - Klinik Birkenwerder
    • Mr.  Dr.med.  Klaus  Ueberreiter 
    • Hubertusstraße 22
    • 16547  Birkenwerder
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/06/15
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Trial Publications, Results and other Documents

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