The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00872859

Enrollment

128

Registered

2009-03-31

Start date

2008-10-31

Completion date

2015-02-28

Last updated

2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Reconstructive Surgery

Keywords

Breast Cancer, Cancer of Breast, Reconstructive Surgery

Brief summary

Primary Hypothesis: 1\. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction Secondary hypotheses: 1. The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation. 2. Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation. 3. Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix Specific aims: 1. Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation 2. Compare the complication rates between the two types of acellular dermal matrix 3. Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation. 4. Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation

Interventions

PROCEDUREImplantation of Dermal Matrix substitute

Dermal Matrix implanted in post mastectomy pts at time of mastectomy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy * Female gender * Age between 18 and 80 * Consent to participate in the study

Exclusion criteria

* Patients not undergoing breast reconstruction following mastectomy * Patients undergoing delayed breast reconstruction following mastectomy * Patients undergoing immediate definitive breast reconstruction after mastectomy * Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction * Medical debility precluding surgical treatment * Prior breast or chest wall irradiation * Pregnant patients * Male gender

Design outcomes

Primary

Measure	Time frame
Effects of radiation on acellular dermal matrix	four years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026