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Completed

NCT Number: NCT03064893

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

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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Key information

Age range

20 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alloderm

Device

Reconstruction material

Dermacell

Device

Reconstruction material

Primary outcomes

  1. Postoperative Duration of Drain Placements

    Time frame: within 6 months of initial surgery

    Postoperative duration of drain placements for each postoperative breast.

Secondary outcomes

  1. Number of Breasts With an Episode of Seroma Formation Requiring Aspiration

    Time frame: within 6 months of initial surgery

  2. Number of Breasts With Loss of Implant

    Time frame: within 6 months of initial surgery

  3. Number of Breasts With Events of Revisional Surgery/ Return to Operating Room

    Time frame: within 6 months of initial surgery

  4. Number of Breasts With Wound Dehiscence or Debridement

    Time frame: within 6 months of initial surgery

    Wound dehiscence is a post-operative complication. Wound debridement is a procedure. This outcome was collected on a post-surgery case report form.

  5. Number of Breasts With Capsular Contracture (as Identified by the Plastic Surgeon)

    Time frame: within 6 months of initial surgery

    Capsular contracture is a post-operative complication identified by the plastic surgeon. This outcome was collected on a post-surgery case report form.

  6. Number of Plastic Surgeon Visits

    Time frame: within 6 months of initial surgery

  7. Economics of Total Costs

    Time frame: 2 years

    Economic impact will be assessed based on calculation of total costs with each material used to include the material costs, duration of operative room use, clinic and inpatient hospital costs, surgical billing costs and anaesthesia costs

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction

Acronym: REaCT-ADM

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 27, 2017
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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