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A Comparison of Dermal Autograft to Commercially Available Dermal Allograft in Breast Reconstruction

Phase 4
Open (Enrolling)
Mastectomy Followed by Tissue Expander/Implant Reconstruction

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Trial Information

A Comparison of Dermal Autograft to Commercially Available Dermal Allograft in Breast Reconstruction

This is a retrospective comparative study of two established therapies. It is designed to
enroll patients who will be undergoing breast reconstruction with tissue expanders/implants.
Two groups will be created. One with patients receiving acellular dermal allograft for
submuscular coverage and a second group of patients undergoing dermal autograft for
submuscular coverage. Patients with a lower abdominal scar and sufficient abdominal laxity
for autograft harvest will be offered this technique. The subset of these patients who
elect to undergo autografting will comprise the autograft group. The allograft group will
consist of the patients without a suitable abdomen for autografting and those who decline
the autograft procedure. Patients in the allograft group will have placement of dermal
allograft over the lower pole of the tissue expander. Patients in the 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. The following data will
be recorded in an unidentifiable fashion: age, medical history, type of breast cancer
treatment, type of reconstruction to include implant type, brand, implant size and
characteristics, time of surgery including autograft harvest, and cost of overall procedure.
Patients will receive routine follow-up care only, and the presence of any complications
will be recorded. Per the standard reconstructive sequence for implant-based breast
reconstruction, all patients will undergo a second surgical procedure under general
anesthesia approximately three months following the initial surgical procedure for
replacement of the tissue expander with a permanent implant and capsulotomy. At the time of
this procedure, three small samples of the internal capsule will be harvested from standard
locations with a 4mm biopsy punch. Histology with H/E and factor VIII staining will be
performed on these samples to measure inflammation, tissue architecture, and vascular
ingrowth. Comorbidities between patients with and without acellular dermal matrices will be
evaluated using the Fisher exact test. Group differences for continuous variables will be
assessed with the t test.

Statistical significance will be defined as p < 0.05.

Inclusion Criteria:

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

Exclusion Criteria:

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Vascular Ingrowth

Outcome Description:

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.

Outcome Time Frame:

Three months post-surgery

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

July 2011

Completion Date:

Related Keywords:

  • Mastectomy Followed by Tissue Expander/Implant Reconstruction



University of Kentucky Chandler Medical Center Lexington, Kentucky  40536