A Study of a Novel Silicone Dressing to Minimize Scar Formation (REFINE)

Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer

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 scarring in post-incision skin tissue. It is expected that by managing the incision site during the healing phase, scar formation may be minimized.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Atherton, California, United States, 94027
      • Atherton Plastic Surgery
    • Bakersfield, California, United States, 93308
      • Vipul R. Dev MD
    • Danville, California, United States, 94526
      • Elite MD
    • Folsom, California, United States, 95630
      • Kaufman and Clark Plastic Surgery
    • Fullerton, California, United States, 92835
      • The Aesthetic Institute
    • Mountain View, California, United States, 94040
      • The Korman Group
    • Newport Beach, California, United States, 92660
      • Newport Plastic Surgery
    • Palo Alto, California, United States, 94304
      • Lauren Greenberg, MD
    • Santa Rosa, California, United States, 95409
      • Plastic Surgery Associates of Santa Rose
    • Walnut Creek, California, United States, 94598
      • Joseph Mele, MD
  • Texas
    • Arlington, Texas, United States, 76011
      • Academy of Clinical Research
    • Dallas, Texas, United States, 75390-9132
      • The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery
    • Fort Sam Houston, Texas, United States, 78234
      • US Army Institute of Surgical Research

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:

• Subjects who have undergone a de novo abdominoplasty.
• Appearance of subject's incision is aesthetically similar across length of incision.

Exclusion Criteria:

• Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
• Subjects diagnosed with scleroderma.
• 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.
• Subjects with a body mass index (BMI) > 30.
• Subjects with a weight loss of greater than or equal to 100 lbs within 6 months from date of abdominoplasty.
• Subjects who currently smoke.
• Subjects taking steroid therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All Study Participants; Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator's standard of care. Participant served as his own control.	Device: embrace device; Adhesive bandage/dressing intended to minimize scar formation.; Other Names: Neodyne Device; embrace dressing; 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.	12 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.
• Collaborators: U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Rodney J Rohrich, MD, FACS, University of Texas Southwestern Medical Center

Publications and helpful links

General Publications

• Longaker MT, Rohrich RJ, Greenberg L, Furnas H, Wald R, Bansal V, Seify H, Tran A, Weston J, Korman JM, Chan R, Kaufman D, Dev VR, Mele JA, Januszyk M, Cowley C, McLaughlin P, Beasley B, Gurtner GC. A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation. Plast Reconstr Surg. 2014 Sep;134(3):536-546. doi: 10.1097/PRS.0000000000000417.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: July 19, 2011
• First Posted (Estimate): July 21, 2011

Study Record Updates

• Last Update Posted (Estimate): December 25, 2014
• Last Update Submitted That Met QC Criteria: December 17, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: scar; wound healing; post-surgical; incision; scarring
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: CA003; 00016580 (Other Grant/Funding Number: Armed Forces Institute of Regenerative Medicine)