A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction

Summary

Breast Cancer affects about 1 out of 8 American women. Twenty percent of breast cancer patients undergo some form of breast reconstruction. Several types of reconstructive procedures are available for appropriate patients. A reconstructive sequence consisting of a tissue expander followed by permanent implant placement is a popular choice for many women. In the past several years, acellular dermal matrices (allografts) have been used at the time of tissue expander placement to extend submuscular coverage. Reported benefits include the ability to initially fill the expander to a greater extent, improved control of the inframammary crease, and possible decrease in capsular contracture rate. Potential disadvantages of dermal allografts include foreign body reaction, incomplete tissue integration, or increased infection rates. The latter is especially worrisome, as infection in the setting of a tissue expander often necessitates the removal of the implant and interruption of the reconstructive sequence. There have been a few scattered reports of the use of dermal autografts in implant-based breast reconstruction, but they have not been widely used. Dermal autografts carry the potential benefit of improved tissue integration and lowered complication rates. However, to date there have been no studies which compare acellular dermal allograft matrices to dermal autograft for use in breast reconstruction. The objectives of this study are to compare dermal allograft to dermal autograft with respect to cost, tissue integration, patient satisfaction with scar, and complication profile in patients undergoing mastectomy followed by tissue expander/implant reconstruction.

Conditions

• Mastectomy Related Lymphedema
• Breast Reconstruction
• Breast Cancer

Interventions

PROCEDURE

Dermal Autograft

Patients in the dermal autograft group will undergo harvest of a dermal autograft from the lower abdomen at the time of mastectomy, which will be used to cover the lower pole of the tissue expander.

PROCEDURE

AlloDerm

The acellular dermal matrix used in our study is AlloDerm (LifeCell Corp., Branchburg, N.J.) The AlloDerm group will consist of patients without a suitable abdomen for autografting and those who declined the dermal autograft procedure. Patients in the dermal allograft group will have placement of AlloDerm over the lower pole of the tissue expander. Patients with a lower abdominal scar and sufficient abdominal laxity for autograft harvest will be offered this technique.

Sponsors & Collaborators

• The Aesthetic Surgery Education & Research Foundation

  collaborator OTHER

• University of Kentucky

  lead OTHER

Principal Investigators

• Brian D Rinker, MD · University of Kentucky

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2016-05-31

Completion

2016-05-31

Countries

• United States

Study Locations