Clinical trial NCT04661501: BREAST ADM Trial for Alloplastic Breast Reconstruction
Official title: The BREAST Trial: A Randomized, Non-inferiority, Study Comparing the Complication Profile of Four Commercially Available Acellular Dermal Matrixes Used in Alloplastic Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Reconstruction
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 328
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is a randomized single blinded prospective clinical trial comparing the surgical outcomes of four different acellular dermal matrixes (ADMs) after primary breast reconstruction. ADMs are used in conjunction with tissue expanders or breast implants to reinforce the recreated breast pocket. Currently, 4 different ADMS are commercially available: AlloDerm, DermaCell, Allomax and Flex HD. It is unclear which ADM is clinically superior. The objective of the study is to compare the complications and post-op care of 4 different ADMs within a 2 year follow up to elucidate their surgical outcomes.

Detailed description: This study is a randomized control trial and will include all patients who are agreeable and deemed appropriate for alloplastic breast reconstruction involving the use of an ADM with two stage tissue expander (TE) reconstruction. The ADMs used will be determined by random assignment to one of four available products being utilized within the study: AlloDerm, AlloMax, DermACELL and FlexHD. Each ADM product will comprise of an individual treatment arm. Participants undergoing bilateral reconstruction will have the same ADM used in each side. The four treatment arms will be compared to assess their impact on our primary outcome: proportion of clinically significant post-operative seroma requiring intervention. Analysis will be performed per surgeon to prevent post-operative outcomes from being confounded by the principle operator. The trial will initially be conducted as an internal pilot study. The study will initially target a study population of 40 patients for recruitment as a means to assess the feasibility of the study. In doing this, the pilot study will be able to establish the necessary protocol and administrative infrastructure that is needed to complete the trial in its entirety. This create a sample population for initial outcomes.

Eligibility criteria: Inclusion Criteria:

* All woman aged 21 years or older but less that 65 undergoing unilateral or bilateral mastectomy with alloplastic breast reconstruction using ADM.
* Breast reconstruction must be done by means of a two staged process using tissue expanders and ADM based reconstruction followed by implant tissue expander to implant exchange.

Exclusion Criteria:

* Patients undergoing autologous reconstruction either at the time of mastectomy or in a delayed fashion.
* Patients with a history of previous breast reconstruction procedures.
* Patients with prior radiation treatment to the breast or with prior mantle radiation
* Any patient with a contraindication to breast reconstruction
* Patients undergoing an axillary node dissection with clearance
* Patients with an allergy to Polysporin or any of its ingredients.
* Patients with contraindications to any of the acellular dermal matrices:

  • DermACELL: Allergy to Gentamicin, Vancomycin\[12\]
* The surgeon performing the breast reconstruction may also deem a patient ineligible if intraoperatively, there is evidence of significant mastectomy flap ischemia prior to the initiation of the breast reconstruction procedure.

Primary outcomes:
measure: Seroma incidence
timeFrame: Within 6 months of stage I or stage II surgery
Secondary outcomes:
measure: Mean drain duration (Days)
timeFrame: Within 1 month of stage I or stage II surgery
measure: Mean drain output (ml)
timeFrame: Within 1 month of stage I or stage II surgery
measure: Mean seroma volume (ml)
timeFrame: Within 6 months of stage I or stage II surgery
measure: Mean aspirations per seroma
timeFrame: Within 6 months of stage I or stage II surgery
measure: Hematoma incidence
timeFrame: Within 1 month of stage I or stage II surgery
measure: Surgical site infection incidence
timeFrame: Within 6 months of stage I or stage II surgery
measure: Number of Participants with Implant loss
timeFrame: Within 2 year of stage II surgery
measure: Number of Participants with Red breast syndrome
timeFrame: Within 1 month of stage I surgery
measure: Number of Participants with Unplanned surgical care
timeFrame: Within 2 year of stage I or stage II surgery
measure: Number of Participants with Mastectomy flap necrosis
timeFrame: Within 1 month of stage I surgery
measure: Capsular contracture incidence
timeFrame: Within 1 year of stage II surgery
measure: ADM integration assessment
timeFrame: Within 1 month of stage II procedure
measure: Post-operative aesthetic assessment (patient and surgeon)
timeFrame: Within 2 years of stage II surgery
measure: Pre and post-operative satisfaction assessed using BREAST-Q
timeFrame: Within 2 years of stage II surgery
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Mount Saint Joseph's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: UBC Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Saint Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Dr. Nancy Van Laeken
role: PRINCIPAL_INVESTIGATOR
References: