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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic
• Intervention / Treatment: Device: embrace device

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94306
      • Duet Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Neodyne dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS)	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.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Subject and Investigator Satisfaction With the Aesthetic Results	Up to 12 months
Ease of Use	Up to 12 months
Comfort Level Related to Study Device Application, Wear and Removal	Up to 12 weeks
Comparison of Scar Smoothness of Treated Side as Compared to the Control Side	Up to 12 months

Collaborators and Investigators

• Sponsor: Neodyne Biosciences, Inc.
• Investigators: Principal Investigator: Jennifer Weintraub, MD, Duet Plastic Surgery; Principal Investigator: Angeline Lim, MD, Duet Plastic Surgery

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 6, 2011
• First Submitted That Met QC Criteria: September 6, 2011
• First Posted (Estimate): September 7, 2011

Study Record Updates

• Last Update Posted (Estimate): November 28, 2014
• Last Update Submitted That Met QC Criteria: November 21, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: scar; wound healing; incision; scarring; scar revision
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: CA005