BREAST ADM Trial for Alloplastic Breast Reconstruction

NCT04661501 | Recruiting

• 1 other identifier: H18-02052
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Seroma incidence

  Incidence of seroma formation requiring intervention including aspiration in-office or ultrasound-guided drainage

  Within 6 months of stage I or stage II surgery

Secondary Outcomes (14)

• Mean drain duration (Days)

  Within 1 month of stage I or stage II surgery

• Mean drain output (ml)

  Within 1 month of stage I or stage II surgery

• Mean seroma volume (ml)

  Within 6 months of stage I or stage II surgery

• Mean aspirations per seroma

  Within 6 months of stage I or stage II surgery

• Hematoma incidence

  Within 1 month of stage I or stage II surgery

Study Arms (4)

AlloDerm group

ACTIVE COMPARATOR

Device for immediate implant based breast reconstruction.

Device: AlloDerm

AlloMax group

ACTIVE COMPARATOR

Device for immediate implant based breast reconstruction.

Device: AlloMax

DermACELL group

ACTIVE COMPARATOR

Device for immediate implant based breast reconstruction.

Device: DermACELL

Flex HD group

ACTIVE COMPARATOR

Device for immediate implant based breast reconstruction.

Device: Flex HD

Interventions

AlloDerm DEVICE

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.

AlloDerm group

AlloMax DEVICE

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 group

DermACELL DEVICE

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 group

Flex HD DEVICE

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 group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (4)

Mount Saint Joseph's Hospital

Vancouver, British Columbia, V5T 3N4, Canada

RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

UBC Hospital

Vancouver, British Columbia, V6T 1Z7, Canada

RECRUITING

Saint Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

RECRUITING

Study Officials

• Dr. Nancy Van Laeken

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Nancy Van Laeken

CONTACT

604-669-1633; nancy@vanlaeken.com

Raveena Gowda

CONTACT

raveena.gowda@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Treatment information will be non-blinded to the surgical staff who will then proceed to order the appropriate ADM product to be available at the time of the study participants scheduled breast reconstruction. Additionally, randomization will occur independently for each surgeon prevent bias from arising as a result of the surgeon performing the reconstruction.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Division of Plastic Surgery

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: December 10, 2020
• Study Start: November 25, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

CA (4)