NCT01293864

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

November 6, 2017

Status Verified

December 1, 2015

Enrollment Period

5 years

First QC Date

February 10, 2011

Last Update Submit

November 2, 2017

Conditions

Cutis Laxa

Keywords

structural analysis, diffusible proteins, glycosaminoglycans

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Subjects younger then 18 years of age or older than 65 years of age, and are not having excxess skin surgically removed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University School of Medicine, Department of Plastic & Reconstructive Surgery

Winston-Salem, North Carolina, 27157-1075, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Abdominal tissue

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Michael J Morykwas, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

April 1, 2007

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

November 6, 2017

Record last verified: 2015-12

Locations

US(1)