A Study of a Novel Silicone Dressing to Minimize Scar Formation
NCT ID: NCT01399099
Last Updated: 2024-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
67 participants
INTERVENTIONAL
2011-06-30
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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embrace Dressing
Investigational Dressing
embrace device
Adhesive bandage/dressing intended to minimize scar formation.
Standard of Care
Standard of care comparator
No interventions assigned to this group
Interventions
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embrace device
Adhesive bandage/dressing intended to minimize scar formation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Appearance of subject's incision is aesthetically similar across length of incision.
Exclusion Criteria
* Subjects diagnosed with scleroderma.
* Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives.
* Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
* Subjects with inability to maintain adequate care of incision.
* Subjects with a body mass index (BMI) \> 30.
* Subjects with a weight loss of greater than or equal to 100 lbs within 6 months from date of abdominoplasty.
* Subjects who currently smoke.
* Subjects taking steroid therapy.
18 Years
65 Years
ALL
No
Sponsors
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U.S. Army Medical Research and Development Command
FED
Neodyne Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rodney J Rohrich, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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Atherton Plastic Surgery
Atherton, California, United States
Vipul R. Dev MD
Bakersfield, California, United States
Elite MD
Danville, California, United States
Kaufman and Clark Plastic Surgery
Folsom, California, United States
The Aesthetic Institute
Fullerton, California, United States
The Korman Group
Mountain View, California, United States
Newport Plastic Surgery
Newport Beach, California, United States
Lauren Greenberg, MD
Palo Alto, California, United States
Plastic Surgery Associates of Santa Rose
Santa Rosa, California, United States
Joseph Mele, MD
Walnut Creek, California, United States
Academy of Clinical Research
Arlington, Texas, United States
The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery
Dallas, Texas, United States
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States
Countries
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References
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Longaker MT, Rohrich RJ, Greenberg L, Furnas H, Wald R, Bansal V, Seify H, Tran A, Weston J, Korman JM, Chan R, Kaufman D, Dev VR, Mele JA, Januszyk M, Cowley C, McLaughlin P, Beasley B, Gurtner GC. A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation. Plast Reconstr Surg. 2014 Sep;134(3):536-546. doi: 10.1097/PRS.0000000000000417.
Other Identifiers
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00016580
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CA003
Identifier Type: -
Identifier Source: org_study_id
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