The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction (REaCT-ADM)

Ottawa Hospital Research Institute

Status: Completed

Conditions: Breast Reconstruction

Treatments: Device: Dermacell; Device: Alloderm

Study type: Interventional

Funder types: Other

Identifiers

NCT03064893

OTT 16-06

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Dermacell

Active Comparator group

Description:

Device for immediate implant based breast reconstruction

Treatment:

Device: Dermacell

Alloderm

Active Comparator group

Description:

Device for immediate implant based breast reconstruction

Treatment:

Device: Alloderm