Status:
COMPLETED
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Women's College Hospital
Vancouver General Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
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. This procedure...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00956384
Start Date
September 1 2009
End Date
December 31 2017
Last Update
December 5 2024
Active Locations (4)
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1
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
2
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
3
Plastic Surgery, Women's College Hospital
Toronto, Ontario, Canada, M5G 1N8
4
Plastic and Reconstructive Surgery, University Health Network
Toronto, Ontario, Canada, M5G 2C4