A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction

NCT01561287 | Completed Phase 4

• 1 other identifier: 10-0595-F2L
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Vascular Ingrowth

  To accurately measure the neovascularization of the implants, the number of blood vessels per 40x high-power field (hpf) will be counted on the slides stained with Factor VIII. Any brown-staining endothelial cell or endothelial-cell cluster, clearly separate from adjacent microvessel and other connective-tissue elements, will be considered a single, countable microvessel. Vessel lumens, although usually present, will not be necessary for a structure to be defined as a microvessel, and red cells will not be used to define a vessel lumen.

  Three months post-surgery

Study Arms (2)

Dermal Autograft

EXPERIMENTAL

Procedure: Dermal Autograft

AlloDerm

EXPERIMENTAL

Procedure: AlloDerm

Interventions

Dermal Autograft PROCEDURE

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.

Dermal Autograft

AlloDerm PROCEDURE

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.

AlloDerm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Only patients who underwent tissue expander/implant breast reconstruction will be included

You may not qualify if:

• Patients without the presence of breast cancer or with the presence of the BRCA gene will be excluded

Sponsors & Collaborators

• University of Kentucky: lead
• The Aesthetic Surgery Education & Research Foundation: collaborator

Study Sites (1)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Alloderm

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Brian D Rinker, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Surgery

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 23, 2012
• Study Start: July 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

US (1)