A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction
Primary Purpose
Mastectomy Related Lymphedema, Breast Reconstruction, Breast Cancer
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dermal Autograft
AlloDerm
Sponsored by
About this trial
This is an interventional supportive care trial for Mastectomy Related Lymphedema
Eligibility Criteria
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
Sites / Locations
- University of Kentucky Chandler Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dermal Autograft
AlloDerm
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01561287
First Posted
March 20, 2012
Last Updated
May 10, 2016
Sponsor
University of Kentucky
Collaborators
The Aesthetic Surgery Education & Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01561287
Brief Title
A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction
Official Title
A Comparison of Dermal Autograft to Commercially Available Dermal Allograft in Breast Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky
Collaborators
The Aesthetic Surgery Education & Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy Related Lymphedema, Breast Reconstruction, Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dermal Autograft
Arm Type
Experimental
Arm Title
AlloDerm
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Dermal Autograft
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
AlloDerm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vascular Ingrowth
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.
Time Frame
Three months post-surgery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian D Rinker, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
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A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction
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