A Study of a Novel Silicone Dressing to Minimize Scar Formation

Hypertrophic Clinical Trial

— REFINE  

Official title:

Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399099
• Other study ID #: CA003
• Secondary ID: 00016580
• Status: Completed
• Phase: N/A
• First received: June 27, 2011
• Last updated: December 17, 2014
• Start date: June 2011
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: Neodyne Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophic

Intervention

Device:
• embrace device
Adhesive bandage/dressing intended to minimize scar formation.

Locations

Country	Name	City	State
United States	Academy of Clinical Research	Arlington	Texas
United States	Atherton Plastic Surgery	Atherton	California
United States	Vipul R. Dev MD	Bakersfield	California
United States	The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery	Dallas	Texas
United States	Elite MD	Danville	California
United States	Kaufman and Clark Plastic Surgery	Folsom	California
United States	US Army Institute of Surgical Research	Fort Sam Houston	Texas
United States	The Aesthetic Institute	Fullerton	California
United States	The Korman Group	Mountain View	California
United States	Newport Plastic Surgery	Newport Beach	California
United States	Lauren Greenberg, MD	Palo Alto	California
United States	Plastic Surgery Associates of Santa Rose	Santa Rosa	California
United States	Joseph Mele, MD	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Neodyne Biosciences, Inc.	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Subject and Investigator Satisfaction With the Aesthetic Results		Up to 12 months	No
Secondary	Ease of Use		Up to 12 months	No
Secondary	Comfort Level Related to Study Device Application, Wear and Removal		Up to 12 weeks	No
Secondary	Comparison of Scar Smoothness of Treated Side as Compared to the Control Side		Up to 12 months	No