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One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure (AllodermRCT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Women's College Hospital
Vancouver General Hospital
Canadian Breast Cancer Foundation
Tom Baker Cancer Centre
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00956384
First received: August 7, 2009
Last updated: March 21, 2016
Last verified: March 2016
  Purpose
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 has been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. The primary drawback, however, is that it requires two separate procedures under general anesthesia and multiple office visits for expander inflation to create the breast mound. Acellular dermal matrix has gained widespread acceptance for use in breast reconstruction and other areas and has the potential to provide support to the breast implant without tissue expansion in a one-stage procedure. The purpose of the study is to test this new procedure and to evaluate the impact of one-stage breast reconstruction using acellular dermis compared to the standard two-stage expander/implant technique on measures of patient satisfaction and quality of life.

Condition Intervention Phase
Breast Cancer
Procedure: One-stage dermal matrix/implant procedure
Procedure: Two-stage tissue expander/implant procedure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acellular Dermal Matrix in One-Stage Breast Reconstruction: A RCT

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • BreastQ quality of life and satisfaction questionnaire [ Time Frame: Baseline, 2 weeks, 6 and 12 months post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Aesthetic Outcome (panel of experts) [ Time Frame: Baseline and 12 months post-op ] [ Designated as safety issue: No ]
  • Short and long term surgical complication rates [ Time Frame: Baseline, 2 weeks, 6 and 12 months post-op ] [ Designated as safety issue: Yes ]

Enrollment: 198
Study Start Date: September 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One-stage dermal matrix/implant
One-stage breast reconstruction with dermal matrix and implant
Procedure: One-stage dermal matrix/implant procedure
One-stage breast reconstruction with dermal matrix and implant
Other Name: Alloderm
Active Comparator: Two-stage tissue expander/implant
Two-stage breast reconstruction with tissue expander and implant
Procedure: Two-stage tissue expander/implant procedure
Two-stage breast reconstruction with tissue expander and implant

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956384

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Plastic Surgery, Women's College Hospital
Toronto, Ontario, Canada, M5G 1N8
Plastic and Reconstructive Surgery, University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Women's College Hospital
Vancouver General Hospital
Canadian Breast Cancer Foundation
Tom Baker Cancer Centre
Investigators
Principal Investigator: Toni Zhong, MD FRCS(C) University Health Network, Toronto
Principal Investigator: Mitchell Brown, MD FRCS(C) Women's College Hospital
Principal Investigator: Stefan Hofer, MD FRCS(C) University Health Network, Toronto
Principal Investigator: John Semple, MD FRCS(C) Women's College Hospital
Principal Investigator: Brett Beber, MD FRCS(C) Women's College Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00956384     History of Changes
Other Study ID Numbers: PSEF-137034 
Study First Received: August 7, 2009
Last Updated: March 21, 2016
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Breast reconstruction
Early stage
Skin-saving mastectomy
Prophylactic mastectomy
Acellular dermal matrix
BRCA Mutation Carriers

ClinicalTrials.gov processed this record on December 09, 2016