Status:
COMPLETED
A Study of a Novel Silicone Dressing to Minimize Scar Formation
Lead Sponsor:
Neodyne Biosciences, Inc.
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Hypertrophic
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
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 Criteria
Inclusion
- Subjects who have undergone a de novo abdominoplasty.
- Appearance of subject's incision is aesthetically similar across length of incision.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01399099
Start Date
June 1 2011
End Date
March 1 2013
Last Update
November 19 2024
Active Locations (13)
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1
Atherton Plastic Surgery
Atherton, California, United States, 94027
2
Vipul R. Dev MD
Bakersfield, California, United States, 93308
3
Elite MD
Danville, California, United States, 94526
4
Kaufman and Clark Plastic Surgery
Folsom, California, United States, 95630