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

This study has been completed.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01399099
First received: June 27, 2011
Last updated: December 17, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Hypertrophic
Device: embrace device

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer

Resource links provided by NLM:


Further study details as provided by Neodyne Biosciences, Inc.:

Primary Outcome Measures:
  • Visual Analogue Scale (VAS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Subject and Investigator Satisfaction With the Aesthetic Results [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Ease of Use [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Comfort Level Related to Study Device Application, Wear and Removal [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Comparison of Scar Smoothness of Treated Side as Compared to the Control Side [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: June 2011
Study Completion Date: March 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399099

Locations
United States, California
Atherton Plastic Surgery
Atherton, California, United States, 94027
Vipul R. Dev MD
Bakersfield, California, United States, 93308
Elite MD
Danville, California, United States, 94526
Kaufman and Clark Plastic Surgery
Folsom, California, United States, 95630
The Aesthetic Institute
Fullerton, California, United States, 92835
The Korman Group
Mountain View, California, United States, 94040
Newport Plastic Surgery
Newport Beach, California, United States, 92660
Lauren Greenberg, MD
Palo Alto, California, United States, 94304
Plastic Surgery Associates of Santa Rose
Santa Rosa, California, United States, 95409
Joseph Mele, MD
Walnut Creek, California, United States, 94598
United States, Texas
Academy of Clinical Research
Arlington, Texas, United States, 76011
The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery
Dallas, Texas, United States, 75390-9132
US Army Institute of Surgical Research
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Neodyne Biosciences, Inc.
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Rodney J Rohrich, MD, FACS University of Texas Southwestern Medical Center
  More Information

No publications provided by Neodyne Biosciences, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01399099     History of Changes
Other Study ID Numbers: CA003, 00016580
Study First Received: June 27, 2011
Results First Received: December 17, 2014
Last Updated: December 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Neodyne Biosciences, Inc.:
scar
incision
wound healing
scarring
post-surgical

ClinicalTrials.gov processed this record on June 29, 2015