Clinical trial NCT00956384: One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure
Official title: Acellular Dermal Matrix in One-Stage Breast Reconstruction: A RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast reconstruction
Early stage
Skin-saving mastectomy
Prophylactic mastectomy
Acellular dermal matrix
BRCA Mutation Carriers
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Women's College Hospital
name: Vancouver General Hospital
name: Canadian Breast Cancer Foundation
name: Tom Baker Cancer Centre
First posted: 2009-08-11
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: BreastQ Quality of Life and Satisfaction Questionnaire
timeFrame: 12 months post-op
Secondary outcomes:
measure: Number of Participants With Short Term Surgical Complications
timeFrame: 6- months post-op
measure: Number of Participants With Long Term Surgical Complications
timeFrame: 12 months post-op
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Plastic Surgery, Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: Plastic and Reconstructive Surgery, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Toni Zhong, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: Mitchell Brown, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Stefan Hofer, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: John Semple, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: Brett Beber, MD FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.