A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 5/12/2016 |
| Start Date: | July 2011 |
| End Date: | May 2016 |
A Comparison of Dermal Autograft to Commercially Available Dermal Allograft in Breast Reconstruction
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.
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.
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.
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
included
Exclusion Criteria:
- Patients without the presence of breast cancer or with the presence of the BRCA gene
will be excluded
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