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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004234

Enrollment

Registered

2012-07-06

Start date

2012-02-18

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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, addition

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

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

Countries

Finland, France, Germany

Contacts

Public ContactKlaus Ueberreiter

Park - Klinik Birkenwerder

park-kinik-birkenwerder.de033035134000-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026