An Evaluation of Cosmetic Results and Toxicity in the Use of Post-Mastectomy Immediate Reconstruction With a Tissue Expander and Acellular Dermal Matrix Followed by Radiation Therapy
- ADMs have been used in combination with a tissue expander and radiotherapy but have not
been studied formally in terms of their ability to avoid complications sometimes seen
with other methods of reconstruction and improve the delivery of the radiation. The
only difference between being on the study and not being on the study is that the
research team will analyze the records of those who participate to see how easy it was
to give the radiation, how good the cosmetic outcome of the reconstruction is and what,
if any, complications occured.
- A minimum of 6 weeks between the surgery and the start of radiation therapy is required
to allow for adequate healing. Often this interval will be longer, as many patients
will receive chemotherapy in the interim. There is no maximum time from surgery to
- Around the time of radiation planning, the radiation oncologist and plastic surgeon
will agree upon how much deflation of the tissue expander will be required to permit
simulation of the radiation therapy.
- Radiation therapy to the chest wall (with or without adjacent lymph nodes) will be
given once daily Monday through Friday over 5-7 weeks.
- After the completion of the radiation therapy, the tissue expander will be re-expanded
and eventually replaced by the permanent implant or flap reconstruction at the
discretion of the plastic surgeon.
- Participants will be expected to return to the Radiation Oncology Clinic for follow-up
visits 6, 12, 18 and 24 months after the end of the radiation therapy. Evaluation of
cosmetic results and complications will be done at these visits using a recognized
scoring system and photographs taken at each time point and scored for specific items
(necrosis, telangiectasia, etc).
Observational Model: Cohort, Time Perspective: Prospective
The success rate of immediate reconstruction with a tissue expander and acellular dermal matrix followed by radiation therapy.
Outcomes will be measured by the ability to complete RT and placement of the permanent implant and/or flap reconstruction, the absence of significant complications, and an acceptable cosmetic result. Major complications are defined as: infection requiring hospitalization, major revisions, early capsular contracture, or pain requiring implant removal. An acceptable cosmetic result (excellent or good, on a scale of excellent-good-fair-poor) is defined as: a stable reconstruction with good symmetry and contour relative to the contralateral breast. The rate of complications and the cosmetic outcome after RT will be recorded by the radiation oncologist at predetermined times (6, 12, 18 and 24 months) after completion of RT and by the plastic surgeon at follow-up visits using photographs.
Julia Wong, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|