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Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE) (IMPROVE)

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. Identifier: NCT01430130
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : November 28, 2014
Last Update Posted : November 28, 2014
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 the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures
Study Start Date : September 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

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

Primary Outcome Measures :
  1. Visual Analogue Scale (VAS) [ Time Frame: 6 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:

  • The scar to be revised is:

    • at least 12 months old
    • linear and suitable for revision by excision and direct closure
    • appropriate size and location for Neodyne Dressing
  • The subject:

    • age > 18 and < 65 years old

Exclusion Criteria:

  • Subjects with a skin disorder that is chronic or currently active.
  • Subjects who are involved in ongoing litigation in connection with the scar to be revised.
  • Subjects with a history of collagen vascular disease
  • Subjects diagnosed with scleroderma
  • Subject who currently smokes
  • 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.

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 identifier (NCT number): NCT01430130

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United States, California
Duet Plastic Surgery
Palo Alto, California, United States, 94306
Sponsors and Collaborators
Neodyne Biosciences, Inc.
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Principal Investigator: Jennifer Weintraub, MD Duet Plastic Surgery
Principal Investigator: Angeline Lim, MD Duet Plastic Surgery
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Responsible Party: Neodyne Biosciences, Inc. Identifier: NCT01430130    
Other Study ID Numbers: CA005
First Posted: September 7, 2011    Key Record Dates
Results First Posted: November 28, 2014
Last Update Posted: November 28, 2014
Last Verified: November 2014
Keywords provided by Neodyne Biosciences, Inc.:
wound healing
scar revision
Additional relevant MeSH terms:
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Pathological Conditions, Anatomical