Status:
COMPLETED
Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)
Lead Sponsor:
Neodyne Biosciences, Inc.
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 the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer...
Eligibility Criteria
Inclusion
- The scar to be revised is:
- at least 12 months old
- linear and suitable for revision by excision and direct closure
- appropriate size and location for Neodyne Dressing
- The subject:
- age \> 18 and \< 65 years old
Exclusion
- Subjects with a skin disorder that is chronic or currently active.
- Subjects who are involved in ongoing litigation in connection with the scar to be revised.
- Subjects with a history of collagen vascular disease
- Subjects diagnosed with scleroderma
- Subject who currently smokes
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01430130
Start Date
September 1 2011
End Date
November 1 2012
Last Update
November 28 2014
Active Locations (1)
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1
Duet Plastic Surgery
Palo Alto, California, United States, 94306