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

NCT ID: NCT00956384

Last Updated: 2024-12-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-01

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Keywords

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Breast reconstruction Early stage Skin-saving mastectomy Prophylactic mastectomy Acellular dermal matrix BRCA Mutation Carriers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One-stage dermal matrix/implant

One-stage breast reconstruction with dermal matrix and implant

Group Type EXPERIMENTAL

One-stage dermal matrix/implant procedure

Intervention Type PROCEDURE

One-stage breast reconstruction with dermal matrix and implant

Two-stage tissue expander/implant

Two-stage breast reconstruction with tissue expander and implant

Group Type ACTIVE_COMPARATOR

Two-stage tissue expander/implant procedure

Intervention Type PROCEDURE

Two-stage breast reconstruction with tissue expander and implant

Interventions

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One-stage dermal matrix/implant procedure

One-stage breast reconstruction with dermal matrix and implant

Intervention Type PROCEDURE

Two-stage tissue expander/implant procedure

Two-stage breast reconstruction with tissue expander and implant

Intervention Type PROCEDURE

Other Intervention Names

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Alloderm

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women's College Hospital

OTHER

Sponsor Role collaborator

Vancouver General Hospital

OTHER

Sponsor Role collaborator

Canadian Breast Cancer Foundation

OTHER

Sponsor Role collaborator

Tom Baker Cancer Centre

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toni Zhong, MD FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Mitchell Brown, MD FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Stefan Hofer, MD FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

John Semple, MD FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Brett Beber, MD FRCS(C)

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

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Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Plastic Surgery, Women's College Hospital

Toronto, Ontario, Canada

Site Status

Plastic and Reconstructive Surgery, University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Zhong T, Temple-Oberle C, Hofer SO, 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.

Reference Type DERIVED
PMID: 24165392 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PSEF-137034

Identifier Type: -

Identifier Source: org_study_id