A Study of a Novel Silicone Dressing to Minimize Scar Formation - Full Text View

Sponsor:	Neodyne Biosciences, Inc.
Collaborator:	Armed Forces Institute of Regenerative Medicine
Information provided by:	Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT01399099

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
Post-surgical Scar Formation	Device: Neodyne Dressing

Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

MedlinePlus related topics: Scars

U.S. FDA Resources

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

Primary Outcome Measures:

Difference between the assessments of the scar appearance for the treated as compared to the control incision sites [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incisions will be evaluated by an objective independent expert panel at 6 months post-surgery.

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 ]
Measured using a scar assessment scale

Estimated Enrollment:	100
Study Start Date:	June 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treated Neodyne Dressing applied to 1/2 of an incision	Device: Neodyne Dressing Adhesive bandage/dressing intended to minimize scar formation. Other Name: Neodyne Device
No Intervention: Control Standard of care used for 1/2 of an incision.

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

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

Contacts

Contact: Angie Maurer, RN, BSN	510-673-2877	amaurer@neodynebio.com
Contact: Rich Caligaris	650-543-7122	rcaligaris@neodynebio.com

Locations

United States, California
	Recruiting
Atherton, California, United States, 94027
	Recruiting
Bakersfield, California, United States, 93308
	Recruiting
Beverly Hills, California, United States, 90210
	Recruiting
Danville, California, United States, 94526
	Recruiting
Folsom, California, United States, 95630
	Recruiting
Fullerton, California, United States, 92835
	Recruiting
Marina Del Rey, California, United States, 90292
	Recruiting
Mountain View, California, United States, 94040
	Recruiting
Newport Beach, California, United States, 92660
	Recruiting
Palo Alto, California, United States, 94304
	Recruiting
Santa Rosa, California, United States, 95409
	Not yet recruiting
Travis Air Force Base, California, United States, 94535
	Recruiting
Walnut Creek, California, United States, 94598
United States, Texas
	Recruiting
Arlington, Texas, United States, 76011
The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery	Not yet recruiting
Dallas, Texas, United States, 75390-9132
Principal Investigator: Rodney J Rohrich, MD, FACS
	Recruiting
San Antonio, Texas, United States, 78234

Sponsors and Collaborators

Neodyne Biosciences, Inc.

Armed Forces Institute of Regenerative Medicine

Investigators

Principal Investigator:

Rodney J Rohrich, MD, FACS

The University of Texas Southwestern Medical Center

More Information

No publications provided

Responsible Party:	Bill Beasley - President/COO, Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier:	NCT01399099 History of Changes
Other Study ID Numbers:	CA003, 00016580
Study First Received:	June 27, 2011
Last Updated:	November 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Neodyne Biosciences, Inc.:

scar
incision
Cicatrix
wound healing
scarring

Additional relevant MeSH terms:

Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012