Structural Analysis of Human Tissue
| Tracking Information | |||||
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| First Received Date ICMJE | February 10, 2011 | ||||
| Last Updated Date | February 10, 2011 | ||||
| Start Date ICMJE | April 2007 | ||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Structural Analysis of Human Tissue | ||||
| Official Title ICMJE | Structural Analysis of Human Tissue | ||||
| Brief Summary | The object of this study is to analyze fresh human skin samples using several up-to-date technologies to get parameters on the mechanical, biochemical and structural distribution of the main components of the capillary-tissue unit. Our working hypothesis is that both structural components of the dermis are not evenly distributed along parallel planes. The investigators further hypothesize the the distribution patterns determine functional and mechanical differences along dermal layers. |
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| Detailed Description | Background The skin is a large organ that participates in many protective and homeostatic processes. The functions of the skin can be roughly divided into systemic and local ; both are interrelated but relationships are poorly understood and studying them requires a multiscale approach. Particularly, for the local responses that are mediated by activation of proteolytic and signaling pathways such as coagulation and inflammation, the relevant scale corresponds to the micrometer and nanometer dimensions of cells and macromolecules, respectively. There is very little information on the physicochemical characteristics of the skin at these scales. Objective The investigators propose to analyze fresh human skin samples using several up-to-date technologies to obtain parameters on the mechanical, biochemical and structural distribution of the main components of the capillary-tissue unit. Hypothesis/Rationale Our working hypothesis is that both structural components of the dermis, such as glycosaminoglycans, and key mediators of homeostatic pathways, such as the procoagulant tissue factor are not evenly distributed along parallel planes. The investigators further hypothesize that the distribution patterns determine functional and mechanical differences along dermal layers. Methods Using a dermatome, human skin will be dissected along planes parallel to the epidermis into several layers each approximately .0012mm thick. The layers will be analyzed with respect to composition of diffusible proteins and glycosaminoglycans; subjected to high resolution MRI and AFM scanning; and evaluated for swelling rate and equilibrium swelling pressure. Significance This study will provide new information on material characteristics and functional structure of the human skin at resolutions relevant to the macromolecular and cellular processes that mediate local responses to injury and maintain local homeostatic mechanisms. The data will be further processed to obtain realistic parameters that are needed to develop predictive models of the skin capillary tissue unit. These models will bring new and deeper understanding on skin physiology and pathology and will aid in the discovery and testing of new preventive and therapeutic approaches targeting dysfunctions of the local homeostatic balance in the skin. Potentially, by exploiting the versatility of mathematical simulations in the skin model, the findings will also be applicable to other tissue organs. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Abdominal tissue |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Study population consists of patients who are being seen in the Plastic & Reconstructive Surgery Clinic for surgical removal of excess abdominal skin (abdominoplasty). |
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| Condition ICMJE | Abdominal Skin Laxity | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | April 2012 | ||||
| Estimated Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01293864 | ||||
| Other Study ID Numbers ICMJE | IRB00002154 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Michael J. Morykwas, PhD, Wake Forest University Health Sciences | ||||
| Study Sponsor ICMJE | Wake Forest University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Wake Forest University | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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