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A Study of a Novel Silicone Dressing to Minimize Scar Formation (REFINE)

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ClinicalTrials.gov Identifier: NCT01399099
Recruitment Status : Completed
First Posted : July 21, 2011
Results First Posted : December 25, 2014
Last Update Posted : December 25, 2014
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Neodyne Biosciences, Inc.

Brief Summary:
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.

Condition or disease Intervention/treatment Phase
Hypertrophic Device: embrace device Not Applicable

Detailed Description:
It is proposed to study a dressing designed to reduce scarring in post-incision skin tissue. It is expected that by managing the incision site during the healing phase, scar formation may be minimized.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer
Study Start Date : June 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Experimental: All Study Participants
Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator's standard of care. Participant served as his own control.
Device: embrace device
Adhesive bandage/dressing intended to minimize scar formation.
Other Names:
  • Neodyne Device
  • embrace dressing
  • Neodyne Dressing

Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: 12 months ]

    Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006[1]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one decimal place. The independent panel used this to scale the primary outcome.

    [1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006.

Secondary Outcome Measures :
  1. Subject and Investigator Satisfaction With the Aesthetic Results [ Time Frame: Up to 12 months ]
  2. Ease of Use [ Time Frame: Up to 12 months ]
  3. Comfort Level Related to Study Device Application, Wear and Removal [ Time Frame: Up to 12 weeks ]
  4. Comparison of Scar Smoothness of Treated Side as Compared to the Control Side [ Time Frame: Up to 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who have undergone a de novo abdominoplasty.
  • Appearance of subject's incision is aesthetically similar across length of incision.

Exclusion Criteria:

  • Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01399099

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United States, California
Atherton Plastic Surgery
Atherton, California, United States, 94027
Vipul R. Dev MD
Bakersfield, California, United States, 93308
Elite MD
Danville, California, United States, 94526
Kaufman and Clark Plastic Surgery
Folsom, California, United States, 95630
The Aesthetic Institute
Fullerton, California, United States, 92835
The Korman Group
Mountain View, California, United States, 94040
Newport Plastic Surgery
Newport Beach, California, United States, 92660
Lauren Greenberg, MD
Palo Alto, California, United States, 94304
Plastic Surgery Associates of Santa Rose
Santa Rosa, California, United States, 95409
Joseph Mele, MD
Walnut Creek, California, United States, 94598
United States, Texas
Academy of Clinical Research
Arlington, Texas, United States, 76011
The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery
Dallas, Texas, United States, 75390-9132
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Neodyne Biosciences, Inc.
U.S. Army Medical Research and Development Command
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Principal Investigator: Rodney J Rohrich, MD, FACS University of Texas Southwestern Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01399099    
Other Study ID Numbers: CA003
00016580 ( Other Grant/Funding Number: Armed Forces Institute of Regenerative Medicine )
First Posted: July 21, 2011    Key Record Dates
Results First Posted: December 25, 2014
Last Update Posted: December 25, 2014
Last Verified: December 2014
Keywords provided by Neodyne Biosciences, Inc.:
wound healing
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical