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OpenTrials
Completed

NCT Number: NCT01430130

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

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.

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Key information

Conditions

Hypertrophic Cicatrix Fibrosis Hypertrophy Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Surgical Wound Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duet Plastic Surgery

Palo Alto, California, 94306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

embrace device

Device

Adhesive bandage/dressing intended to minimize scar formation.

Other names: Neodyne dressing

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Neodyne Biosciences, Inc.

Industry

Registry information

Official study title

Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures

Acronym: IMPROVE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2011
Registry last updated
Nov 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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