The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-06

Study Completion Date

2019-02-19

Brief Summary

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Breast reconstruction after mastectomy has been shown to provide psychosocial benefits to breast cancer patients and is considered an integral part of breast cancer treatment. In general, breast reconstruction can be accomplished using the patients own tissues or implantable prosthetic devices. Various acellular dermal matrices (ADMs) are offered on the market and the costs vary widely despite very similar qualities. The two most commonly used ADM products in North America by far are Dermacell and Alloderm. The difference between the two products include a) level of sterility, with Dermacell being sterilized to 10-9 while Alloderm is sterilized to 10-6 and b) the consistency and thickness of the biologic material and c) a significant different in cost ($2200 CAD vs $3600, respectively). Each product has shown to be safe and effective. As such, clinical equipoise exists. This will be a pragmatic trial to evaluate Dermacell with Alloderm in a head to head randomized fashion, with regards to the postoperative complications, namely infection, seroma formation (as measured by drain duration and output), loss of implant, incidence of revisional surgery and capsular contracture.

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Detailed Description

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Conditions

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Breast Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dermacell

Device for immediate implant based breast reconstruction

Group Type ACTIVE_COMPARATOR

Dermacell

Intervention Type DEVICE

Reconstruction material

Alloderm

Device for immediate implant based breast reconstruction

Group Type ACTIVE_COMPARATOR

Alloderm

Intervention Type DEVICE

Reconstruction material

Interventions

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Alloderm

Reconstruction material

Intervention Type DEVICE

Dermacell

Reconstruction material

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female patient
* Ages 20-90
* All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction
* Able to provide verbal consent

Exclusion Criteria

* Patients who have had prior chest wall or irradiation on the reconstructed side
* Patients not undergoing immediate breast reconstruction at the time of mastectomy
* Any patient with a contraindication to immediate breast reconstruction

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No