Acellular Dermal Matrix in One-Stage Breast Reconstruction: A RCT
18 Years
75 Years
Female
Breast Cancer
Trial Information
Acellular Dermal Matrix in One-Stage Breast Reconstruction: A RCT
Recently, there has been significant focus on the performance of skin-sparing mastectomies
in certain types of breast cancer patients. These treatments may be performed for
prophylactic mastectomy but also have been demonstrated to be oncologically safe in patients
with specific criteria for early stage breast cancer. Currently, the two-stage tissue
expander/implant (TE/I) technique is the standard breast reconstructive option for breast
cancer patients selected for immediate, skin-sparing mastectomy, however there are
significant disadvantages as this technique requires two separate surgeries and multiple
office visits to complete that may affect a patients quality of life. Medically safe
compounds such as acellular dermal matrix have been developed that have the potential to
support breast implants without requiring numerous tissue expansions and consequently
providing the potential for a one-stage breast implant/reconstruction procedure for
immediate, skin-sparing mastectomies.
To examine patient satisfaction, quality of life and overall aesthetic outcome achieved
using the acellular dermal matrix facilitated one-staged breast reconstruction at 2 weeks, 6
& 12 months following completion of the reconstruction. Hypothesis 2: Patient satisfaction,
quality of life and overall aesthetic outcome achieved using the acellular dermal matrix
facilitated one-stage breast reconstruction is superior to that following the standard
two-stage tissue expander/ implant breast reconstruction technique in selected mastectomy
patients.
To determine the short and long-term operative complication rates associated with the use of
dermal matrix in one-stage immediate breast reconstruction following skin-sparing
mastectomy. Hypothesis 1: The use of acellular dermal matrix in one-stage immediate
prosthetic breast reconstruction is associated with decreased short and long-term
postoperative complications compared with the traditional two staged tissue expander/implant
procedure.
Inclusion Criteria:
- Patients who undergo immediate, implant-based reconstruction following skin-sparing
and nipple-sparing mastectomy.
- Patients who are older than 18 years of age and who understand English enough to
complete the study questionnaires.
Exclusion Criteria:
- Patient refusal, patients with documented psychiatric history of psychosis or mental
disorder excluding depression, patients who are active smokers.
- Patients who will undergo any of the following: Autologous tissue reconstruction,
patients with prior history of radiation or expected to receive post-operative
radiation, patients who are pregnant, patients with grade III ptosis.
- Intraoperative exclusion of those whose mastectomy flaps are deemed to be too thin or
have significant ischemia.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
BreastQ quality of life and satisfaction questionnaire
Outcome Time Frame:
Baseline, 2 weeks, 6 and 12 months post-op
Safety Issue:
No
Principal Investigator
Toni Zhong, MD FRCS(C)
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Toronto
Authority:
Canada: Health Canada
Study ID:
PSEF-137034
NCT ID:
NCT00956384
Start Date:
August 2009
Completion Date:
September 2014
Related Keywords:
- Breast Cancer
- Breast reconstruction
- Early stage
- Skin-saving mastectomy
- Prophylactic mastectomy
- Acellular dermal matrix
- BRCA Mutation Carriers
- Breast Neoplasms
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