Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
Mona Lisa
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 3, 2008
CompletedFirst Posted
Study publicly available on registry
October 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
December 14, 2020
CompletedDecember 14, 2020
December 1, 2020
1.1 years
October 3, 2008
September 15, 2020
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)
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
Study Arms (2)
GLYDe Dressing
EXPERIMENTALInvestigational Dressing
Standard of Care
NO INTERVENTIONStandard of care comparator
Interventions
Eligibility Criteria
You may qualify if:
- subjects who have undergone an abdominoplasty 1 week prior to study participation
You may not qualify if:
- subjects with a history of collagen vascular disease or scleroderma
- subjects with known adverse reactions to steri-strips, medical tapes or adhesives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Josh Korman, MD
Mountain View, California, 94040, United States
Related Publications (1)
Gurtner GC, Dauskardt RH, Wong VW, Bhatt KA, Wu K, Vial IN, Padois K, Korman JM, Longaker MT. Improving cutaneous scar formation by controlling the mechanical environment: large animal and phase I studies. Ann Surg. 2011 Aug;254(2):217-25. doi: 10.1097/SLA.0b013e318220b159.
PMID: 21606834DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP, R&D/OPS
- Organization
- Neodyne
Study Officials
- STUDY DIRECTOR
Michael Longaker, MD
Neodyne Biosciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2008
First Posted
October 6, 2008
Study Start
October 1, 2008
Primary Completion
November 1, 2009
Study Completion
March 1, 2010
Last Updated
December 14, 2020
Results First Posted
December 14, 2020
Record last verified: 2020-12