Structural Analysis of Human Tissue

This study has been terminated.
(This is not a clinical trials study)
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01293864
First received: February 10, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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.


Condition
Abdominal Skin Laxity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Structural Analysis of Human Tissue

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Biospecimen Retention:   Samples Without DNA

Abdominal tissue


Estimated Enrollment: 50
Study Start Date: April 2007
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

Criteria

Inclusion Criteria:

  • Subjects, male or female , between the ages of 18 to 65 years of age, who will be having surgery to remove excess skin from the abdominal area by surgeons in the Department of Plastic & Reconstructive Surgery

Exclusion Criteria:

  • Subjects younger then 18 years of age or older than 65 years of age, and are not having excxess skin surgically removed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293864

Locations
United States, North Carolina
Wake Forest University School of Medicine, Department of Plastic & Reconstructive Surgery
Winston-Salem, North Carolina, United States, 27157-1075
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Michael J Morykwas, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Michael J. Morykwas, PhD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01293864     History of Changes
Other Study ID Numbers: IRB00002154
Study First Received: February 10, 2011
Last Updated: February 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
structural analysis, diffusible proteins, glycosaminoglycans

ClinicalTrials.gov processed this record on September 22, 2014