A Study of a Novel Silicone Dressing to Minimize Scar Formation (REFINE)
This study is ongoing, but not recruiting participants.
Sponsor:
Neodyne Biosciences, Inc.
Collaborator:
Armed Forces Institute of Regenerative Medicine
Information provided by (Responsible Party):
Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01399099
First received: June 27, 2011
Last updated: June 5, 2012
Last verified: June 2012
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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:
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
Locations
| United States, California | |
| Atherton, California, United States, 94027 | |
| Bakersfield, California, United States, 93308 | |
| Beverly Hills, California, United States, 90210 | |
| Danville, California, United States, 94526 | |
| Folsom, California, United States, 95630 | |
| Fullerton, California, United States, 92835 | |
| Marina Del Rey, California, United States, 90292 | |
| Mountain View, California, United States, 94040 | |
| Newport Beach, California, United States, 92660 | |
| Palo Alto, California, United States, 94304 | |
| Santa Rosa, California, United States, 95409 | |
| Travis Air Force Base, California, United States, 94535 | |
| Walnut Creek, California, United States, 94598 | |
| United States, Texas | |
| Arlington, Texas, United States, 76011 | |
| The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery | |
| Dallas, Texas, United States, 75390-9132 | |
| 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 | University of Texas Southwestern Medical Center |
More Information
No publications provided
| Responsible Party: | Neodyne Biosciences, Inc. |
| ClinicalTrials.gov Identifier: | NCT01399099 History of Changes |
| Other Study ID Numbers: | CA003, 00016580 |
| Study First Received: | June 27, 2011 |
| Last Updated: | June 5, 2012 |
| 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 June 17, 2013