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

• Conditions: Post-mastectomy (uni- or bilateral) condition, scar contracture, scar fibrosis; C50.9; Z42.9; Breast, unspecified; Follow-up care involving plastic surgery, unspecified

• Registration Number: DRKS00004234
• Lead Sponsor: Park - Klinik Birkenwerder

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-06-15
• Study Start: 2012-07-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 28

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>2) method's safety: at least 6 months follow-up, mammography or sonography,control of weight changes, foto documentary<br><br>3) patients satisfaction after completed breast reconstruction (at least 6 months): 10-point Linkert scale (3 questions) and optional comments.<br><br>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 Measures

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