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The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial


Phase 3
21 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

The Use of Alloderm in Two-Stage, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial


Inclusion Criteria:



- Patients who undergo immediate, postmastectomy, tissue expander/implant
reconstruction

- Patients ≥ 21 and ≤ 75 years of age

Exclusion Criteria:

- Patient refusal

- Patients who will undergo any of the following:

- Single-stage implant reconstruction

- Combined autogenous tissue expander/implant reconstruction

- Patients with a history of prior irradiation

- Patients with a history of prior surgery with breast implants

- Patients with a history of prior axillary lymph node dissection

- Patients who are pregnant

The following eligibility will be confirmed at the time of surgery.

- Patients who are deemed intraoperatively by the attending surgeon to have significant
mastectomy flap ischemia.

- Patients who have an axillary lymph node dissection at the time of mastectomy
(Patients undergoing sentinel lymph biopsy are eligible)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

whether using Alloderm to create the inferior-medial portion of the expander pocket will decrease patient-reported pain in both the immediate, post-operative period and during the expansion phase.

Outcome Time Frame:

conclusion of the study

Safety Issue:

No

Principal Investigator

Joseph Disa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

08-024

NCT ID:

NCT00639106

Start Date:

March 2008

Completion Date:

March 2013

Related Keywords:

  • Breast Cancer
  • Breast expander
  • Breast reconstruction
  • implants
  • 08-024
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
University of Michigan Health SystemAnn Arbor, Michigan  
University of North Carolina School of MedicineChapel Hill, North Carolina  27599