- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01561287
A Comparison of Dermal Autograft to AlloDerm in Breast Reconstruction
A Comparison of Dermal Autograft to Commercially Available Dermal Allograft in Breast Reconstruction
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky Chandler Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vascular Ingrowth
Time Frame: Three months post-surgery
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian D Rinker, MD, University of Kentucky
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-0595-F2L
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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