Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments one-stage dermal matrix/implant procedure, two-stage tissue expander/implant procedure
Phase phase 3
Sponsor University Health Network, Toronto
Collaborator Women's College Hospital
Start date September 2009
End date December 2016
Trial size 198 participants
Trial identifier NCT00956384, PSEF-137034

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
One-stage breast reconstruction with dermal matrix and implant
one-stage dermal matrix/implant procedure Alloderm
One-stage breast reconstruction with dermal matrix and implant
(Active Comparator)
Two-stage breast reconstruction with tissue expander and implant
two-stage tissue expander/implant procedure
Two-stage breast reconstruction with tissue expander and implant

Primary Outcomes

Measure
BreastQ quality of life and satisfaction questionnaire
time frame: Baseline, 2 weeks, 6 and 12 months post-op

Secondary Outcomes

Measure
Overall Aesthetic Outcome (panel of experts)
time frame: Baseline and 12 months post-op
Short and long term surgical complication rates
time frame: Baseline, 2 weeks, 6 and 12 months post-op

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Acellular Dermal Matrix in One-Stage Breast Reconstruction: A RCT
Principal investigator Toni Zhong, MD FRCS(C)
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.