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

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 4

Conditions: Breast Cancer; Reconstructive Surgery

Treatments: Procedure: Implantation of Dermal Matrix substitute

Study type: Interventional

Funder types: Other

Identifiers

NCT00872859

26658

Details and patient eligibility

About

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

Enrollment: 128 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

128 participants in 4 patient groups

1

Experimental group

Description:

Dermamatrix with radiation

Treatment:

Procedure: Implantation of Dermal Matrix substitute

2

Experimental group

Description:

Dermamatrix without radiation

Treatment:

Procedure: Implantation of Dermal Matrix substitute

3

Experimental group

Description:

Alloderm with radiation

Treatment:

Procedure: Implantation of Dermal Matrix substitute

4

Experimental group

Description:

Alloderm without radiation

Treatment:

Procedure: Implantation of Dermal Matrix substitute