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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University Health Network, Toronto
Sponsor:
Collaborators:
Women's College Hospital
Vancouver General Hospital
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00956384
First received: August 7, 2009
Last updated: February 10, 2014
Last verified: February 2014

August 7, 2009
February 10, 2014
August 2009
December 2014   (final data collection date for primary outcome measure)
BreastQ quality of life and satisfaction questionnaire [ Time Frame: Baseline, 2 weeks, 6 and 12 months post-op ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00956384 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Acellular Dermal Matrix in One-Stage Breast Reconstruction: A RCT

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Procedure: One-stage dermal matrix/implant procedure
    One-stage breast reconstruction with dermal matrix and implant
    Other Name: Alloderm
  • Procedure: Two-stage tissue expander/implant procedure
    Two-stage breast reconstruction with tissue expander and implant
  • Experimental: One-stage dermal matrix/implant
    One-stage breast reconstruction with dermal matrix and implant
    Intervention: Procedure: One-stage dermal matrix/implant procedure
  • Active Comparator: Two-stage tissue expander/implant
    Two-stage breast reconstruction with tissue expander and implant
    Intervention: Procedure: Two-stage tissue expander/implant procedure
Zhong T, Temple-Oberle C, Hofer S, Beber B, Semple J, Brown M, Macadam S, Lennox P, Panzarella T, McCarthy C, Baxter N; MCCAT Study Group. The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction. Trials. 2013 Oct 28;14:356. doi: 10.1186/1745-6215-14-356.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years to 75 Years
Yes
Contact: Toni Zhong, MD 416-340-3858 toni.zhong@uhn.on.ca
Contact: Kate Butler, MHSc 416-340-4800 ext 2343 kbutler@uhnres.utoronto.ca
Canada
 
NCT00956384
PSEF-137034
No
University Health Network, Toronto
University Health Network, Toronto
  • Women's College Hospital
  • Vancouver General Hospital
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
University Health Network, Toronto
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP