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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01399099
Recruitment Status : Completed
First Posted : July 21, 2011
Results First Posted : December 25, 2014
Last Update Posted : December 25, 2014
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Neodyne Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE June 27, 2011
First Posted Date  ICMJE July 21, 2011
Results First Submitted Date  ICMJE December 17, 2014
Results First Posted Date  ICMJE December 25, 2014
Last Update Posted Date December 25, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
Difference between the assessments of the scar appearance for the treated as compared to the control incision sites [ Time Frame: 6 months ]
Incisions will be evaluated by an objective independent expert panel at 6 months post-surgery.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2014)
  • Subject and Investigator Satisfaction With the Aesthetic Results [ Time Frame: Up to 12 months ]
  • Ease of Use [ Time Frame: Up to 12 months ]
  • Comfort Level Related to Study Device Application, Wear and Removal [ Time Frame: Up to 12 weeks ]
  • Comparison of Scar Smoothness of Treated Side as Compared to the Control Side [ Time Frame: Up to 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
  • Subject and Investigator Satisfaction With the Aesthetic Results [ Time Frame: Up to 12 months ]
  • Ease of Use [ Time Frame: Up to 12 months ]
  • Comfort Level Related to Study Device Application, Wear and Removal [ Time Frame: Up to 12 weeks ]
  • Comparison of Scar Smoothness of Treated Side as Compared to the Control Side [ Time Frame: Up to 12 months ]
    Measured using a scar assessment scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of a Novel Silicone Dressing to Minimize Scar Formation
Official Title  ICMJE Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertrophic
Intervention  ICMJE Device: embrace device
Adhesive bandage/dressing intended to minimize scar formation.
Other Names:
  • Neodyne Device
  • embrace dressing
  • Neodyne Dressing
Study Arms  ICMJE 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.
Intervention: Device: embrace device
Publications * 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):536-46. doi: 10.1097/PRS.0000000000000417.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2013)
67
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2011)
100
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01399099
Other Study ID Numbers  ICMJE CA003
00016580 ( Other Grant/Funding Number: Armed Forces Institute of Regenerative Medicine )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neodyne Biosciences, Inc.
Study Sponsor  ICMJE Neodyne Biosciences, Inc.
Collaborators  ICMJE U.S. Army Medical Research and Development Command
Investigators  ICMJE
Principal Investigator: Rodney J Rohrich, MD, FACS University of Texas Southwestern Medical Center
PRS Account Neodyne Biosciences, Inc.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP