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

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: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Standard of care comparator
Experimental: embrace Dressing; Investigational Dressing	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
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	Measure Description	Time Frame
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results	The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively [1]. The POSAS criteria evaluated by the patients in this study were pain, itching, color, stiffness, thickness, irregularity, and overall opinion. The Patient and Observer Scar Assessment Scale (POSAS) ranges from 1 to 10 with 10 being the worst imaginable or most different. [1] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.	6 Months
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results	The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively [1]. The POSAS criteria evaluated by the patients in this study were pain, itching, color, stiffness, thickness, irregularity, and overall opinion. [1] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.	12 Months
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results	The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively [1]. The POSAS criteria evaluated by the observers in this study were vascularity, pigmentation, thickness, relief, pliability, surface area, and an overall opinion. [1] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.	6 Months
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results	The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively [1]. The POSAS criteria evaluated by the observers in this study were vascularity, pigmentation, thickness, relief, pliability, surface area, and an overall opinion. [1] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.	12 Months
Patient Satisfaction - Scar Minimization	Subjects were were asked to compare the embrace-treated side with the control-treated side with regards to their satisfaction with the scar minimization on their incision.	6 Months
Patient Satisfaction - Recommend	Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.	6 Months
Patient Satisfaction - Use Again	Subjects were asked if they were to have another procedure that would leave a scar how likely would they be to use embrace treatment again.	6 Months
Patient Satisfaction - Scar Minimization	Subjects were were asked to compare the embrace-treated side with the control-treated side with regards to their satisfaction with the scar minimization on their incision.	12 Months
Patient Satisfaction - Recommend	Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.	12 Months
Patient Satisfaction - Use Again	Subjects were asked if they were to have another procedure that would leave a scar how likely would they be to use embrace treatment again.	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 (Estimated): July 21, 2011

Study Record Updates

• Last Update Posted (Actual): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

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)