Recruiting

Breast Reconstruction

Sponsor:

University of British Columbia

Code:

NCT04661501

Conditions

Breast Reconstruction

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

AlloDerm

AlloMax

DermACELL

Flex HD

Study Details

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.

Conditions

Breast Reconstruction

Study ID

NCT04661501

Start date

Nov 25, 2020

Status verified date

Dec, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

328 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: AlloDerm group

Device for immediate implant based breast reconstruction.

active comparator: AlloMax group

Device for immediate implant based breast reconstruction.

active comparator: DermACELL group

Device for immediate implant based breast reconstruction.

active comparator: Flex HD group

Device for immediate implant based breast reconstruction.

Interventions

AlloDerm

Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.

AlloMax

Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.

DermACELL

Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.

Flex HD

Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.

Primary outcome measure

  • Seroma incidence [ Time Frame: Within 6 months of stage I or stage II surgery ]

Central Contacts and Locations

Central contacts

Dr. Nancy Van Laeken

604-669-1633nancy@vanlaeken.com

Raveena Gowda

raveena.gowda@ubc.ca

Locations

Mount Saint Joseph's Hospital

Recruiting

Vancouver, British Columbia, Canada, V5T 3N4

Contacts

Dr. Nancy Van Laeken, MD, FRCSC

604-669-1633Nancy@vanlaeken.com

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Dr. Peter Lennox, MD, FRCSC

604-876-6552peter.lennox@ubc.ca

UBC Hospital

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z7

Contacts

Dr. Sheina Macadam, MD, FRCSC

604-876-1688drsmacadam@drsheinamacadam.com

Saint Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Dr. Kathryn Isaac, MD, FRCSC

604-336-8488kathryn.isaac@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Dec 16, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-12-16.