Status:
COMPLETED
Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting?
Lead Sponsor:
Sykehuset Telemark
Conditions:
Breast Cancer
Mammaplasty
Eligibility:
FEMALE
20-70 years
Phase:
NA
Brief Summary
Methods for breast reconstruction after mastectomy vary from rather simple techniques using expanders and implants, local flaps alone or in combination with implants, to more complex methods using aut...
Detailed Description
When used for breast reconstruction on irradiated patients, breast implants can result in 50% or higher rate of complications included capsular contracture and implant rupture. For this reasons second...
Eligibility Criteria
Inclusion
- Women who have consented to participate in the study and underwent mastectomy and radiation therapy.
- Mammography of the remaining breast performed within 3 months before surgery
- At least 1 year after completion of radiotherapy
- BMI between 22 and 32 -
Exclusion
- Patients with recurrent or metastatic breast cancer
- Patients with pacemakers or metal clips after any surgery
- Patients with heart, kidney or liver failure or other medical conditions such as severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes
- Patients with claustrophobia
- Patients with severe drug abuse
- Patients with silicone allergy
- Patients with bleeding disorders
- Patients who smoke or have smoked in the last two months
Key Trial Info
Start Date :
June 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2022
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04273464
Start Date
June 1 2016
End Date
February 1 2022
Last Update
December 7 2022
Active Locations (1)
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1
Telemark Hospital
Skien, Telemark, Norway, 3700