Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01430130
First received: September 6, 2011
Last updated: November 21, 2014
Last verified: November 2014
  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
Hypertrophic
Device: embrace device

Study Type: Interventional
Study Design: 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:


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

Primary Outcome Measures:
  • Visual Analogue Scale (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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:
  • 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 ]

Enrollment: 12
Study Start Date: September 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01430130     History of Changes
Other Study ID Numbers: CA005 
Study First Received: September 6, 2011
Results First Received: November 10, 2014
Last Updated: November 21, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on December 05, 2016