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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00004234
• Date of registration: 06/07/2012
• Prospective Registration: No
• Primary sponsor: Park - Klinik Birkenwerder
• Public title: "De novo" breast reconstruction with autologuos fat grafting in post-mastectomy patients
• Scientific title: "De novo" breast reconstruction with autologuos fat grafting in post-mastectomy patients
• Date of first enrolment: 18/02/2012
• Target sample size: 50
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00004234
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment

Countries of recruitment

Finland, France, Germany

Contacts

• Name: Delia Letizia Hoppe
• Affiliation: Park - Klinik Birkenwerder Fachklinik für Plastische und Ästhetische Chirurgie

• Name: Klaus Ueberreiter
• Affiliation: Park - Klinik Birkenwerder

Key inclusion & exclusion criteria

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
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

Age minimum: 18 Years
Age maximum: None
Gender: Female

Health Condition(s) or Problem(s) studied

Post-mastectomy (uni- or bilateral) condition, scar contracture, scar fibrosis
C50.9
Z42.9

C50.9

Breast, unspecified

Follow-up care involving plastic surgery, unspecified

Z42.9

Intervention(s)

Group 1: 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.

Primary Outcome(s)

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)

Secondary Outcome(s)

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

Source(s) of Monetary Support

Park - Klinik Birkenwerder

Results

• Date Completed: 15/06/2012
• URL: http://drks.de/search/en/trial/DRKS00004234#studyResults