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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01430130
First received: September 6, 2011
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Scar Formation
 Device: Neodyne Dressing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by Neodyne Biosciences, Inc.:

Primary Outcome Measures:
  • Difference between the assessments of the scar appearance for the treated as compared to the control incision sites [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Incisions will be evaluated by an objective independent expert panel at 6 months post-surgery.


Secondary Outcome Measures:
  • Subject and investigator satisfaction with the aesthetic results [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Ease of use [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Comfort level related to study device application, wear and removal [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Comparison of scar smoothness of treated side as compared to the control side [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Measured using a scar assessment scale


Estimated Enrollment: 25
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treated
Neodyne Dressing applied to portion of closed scar.
 Device: Neodyne Dressing
Adhesive bandage/dressing intended to minimize scar formation.
Other Name: Neodyne Device
No Intervention: Control
Standard of care used for portion of closed scar.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430130

Locations
United States, California
Duet Plastic Surgery
Palo Alto, California, United States, 94306
Sponsors and Collaborators
Neodyne Biosciences, Inc.
Investigators
Principal Investigator: Jennifer Weintraub, MD Duet Plastic Surgery
Principal Investigator: Angeline Lim, MD Duet Plastic Surgery
  More Information

No publications provided

Responsible Party: Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01430130     History of Changes
Other Study ID Numbers: CA005
Study First Received: September 6, 2011
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Neodyne Biosciences, Inc.:
scar
incision
Cicatrix
 wound healing
scarring
scar revision

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013