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

NCT00956384 | Completed Results

• 1 other identifier: PSEF-137034
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• BreastQ Quality of Life and Satisfaction Questionnaire

  Compare the change in the patient satisfaction and QOL scores between one-stage ADM-assisted and two-stage TE/I reconstruction without ADM over time (at 2 weeks after mastectomy, at 6 months and at 12 months following the final reconstruction procedure) from baseline scores following reconstruction using the validated BREAST-Q reconstruction module. The BREAST-Q Reconstruction Module is used to measure outcomes across four domains/sub-scales: satisfaction with the breast, psychosocial wellbeing, physical wellbeing, and sexual wellbeing. Each domain is scored on a scale of 1 to 100, with higher scores indicating better quality of life and greater patient satisfaction with more favorable outcomes.

  12 months post-op

Secondary Outcomes (2)

• Number of Participants With Short Term Surgical Complications

  6- months post-op

• Number of Participants With Long Term Surgical Complications

  12 months post-op

Study Arms (2)

One-stage dermal matrix/implant

EXPERIMENTAL

One-stage breast reconstruction with dermal matrix and implant

Procedure: One-stage dermal matrix/implant procedure

Two-stage tissue expander/implant

ACTIVE COMPARATOR

Two-stage breast reconstruction with tissue expander and implant

Procedure: Two-stage tissue expander/implant procedure

Interventions

One-stage dermal matrix/implant procedure PROCEDURE

One-stage breast reconstruction with dermal matrix and implant

Also known as: Alloderm

One-stage dermal matrix/implant

Two-stage tissue expander/implant procedure PROCEDURE

Two-stage breast reconstruction with tissue expander and implant

Two-stage tissue expander/implant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Women's College Hospital: collaborator
• Vancouver General Hospital: collaborator
• Canadian Breast Cancer Foundation: collaborator
• Tom Baker Cancer Centre: collaborator

Study Sites (4)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Plastic Surgery, Women's College Hospital

Toronto, Ontario, M5G 1N8, Canada

Location

Plastic and Reconstructive Surgery, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 24165392 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Implants; Alloderm

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Toni Zhong
• Organization: University Health Network

kbutler@uhnresearch.ca

4163404800

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 11, 2009
• Study Start: September 1, 2009
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: December 5, 2024
• Results First Posted: December 5, 2024

Record last verified: 2024-10

Locations

CA (4)