- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00766727
Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care (Mona Lisa)
December 11, 2020 updated by: Neodyne Biosciences, Inc.
This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients.
The hypothesis is that this dressing will minimize scar formation.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study will evaluate a new dressing in up to 30 patients who have undergone an abdominoplasty procedure.
They will wear the dressing through 8 weeks post surgery and the scar will be evaluated at 3 months post surgery.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Mountain View, California, United States, 94040
- Josh Korman, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- subjects who have undergone an abdominoplasty 1 week prior to study participation
Exclusion Criteria:
- subjects with a history of collagen vascular disease or scleroderma
- subjects with known adverse reactions to steri-strips, medical tapes or adhesives
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GLYDe Dressing
Investigational Dressing
|
Wound dressing intended to minimize scar formation
|
No Intervention: Standard of Care
Standard of care comparator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)
Time Frame: through 12 months
|
Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels.
A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint.
|
through 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael Longaker, MD, Neodyne Biosciences, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
October 3, 2008
First Submitted That Met QC Criteria
October 3, 2008
First Posted (Estimate)
October 6, 2008
Study Record Updates
Last Update Posted (Actual)
December 14, 2020
Last Update Submitted That Met QC Criteria
December 11, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CA001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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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