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Delayed Reconstructioon of Irradiated Breast with fat grafting

Delayed breast reconstruction with autologous fat grafting and implant after mastectomy and radioterapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-57cqdx
Enrollment
Unknown
Registered
2017-10-29
Start date
2017-08-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

breast reconstruction, radio dermatitis, women

Interventions

Delayed total breast reconstruction after radiotherapy 1 - Experimental group: 10 women will receive breast reconstruction with lipofilling (fat harvested via liposuction and injection into the breast
Procedure/surgery
E02.218.565.210

Sponsors

Hospital da Mulher Prof. Dr. José Aristodemo Pinotti -CAISM
Lead Sponsor
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti -CAISM
Collaborator

Eligibility

Sex/Gender
Female
Age
21 Years to 70 Years

Inclusion criteria

Inclusion criteria: Health woman; age between 21 and 70 year-old; who underwent mastectomy followed by radiotherapy, after at least 6 month of adjuvant treatment conclusion and that wish delayed breast reconstruction; agree breast reconstruction with alloplastic material and autologous tissue; woman in oncological follow-up; agree with all necessary procedures, as well as all outpatient returns and proposed photographies; assign the Consent Form; be free of tumor relapse or any radiological alterations

Exclusion criteria

Exclusion criteria: smoking volunteers; history of alcohol or drug abuse; diagnoses of tumor recurrence or radiological alterations in mammary topography; obesity; loss of segment; cognitive difficulties

Design outcomes

Primary

MeasureTime frame
Improvement of the shape and volume of the reconstructed breast, analyzed by clinical examination at the postoperative time of 3 months, 6 months and 12 months

Secondary

MeasureTime frame
Patient´s Satisfaction/ Life quality improvement analyzed through the WHOQOL-100 questionary at the postoperative time of 3 months, 6 months and 12 months

Countries

Brazil

Contacts

Public ContactFrancisco Claro de Oliveira Jr.

Universidade Estaudal de Campinas

fclarojr@gmail.com55-11-993205686

Outcome results

None listed

Source: REBEC (via WHO ICTRP)