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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01399099
Other study ID # CA003
Secondary ID 00016580
Status Completed
Phase N/A
First received June 27, 2011
Last updated December 17, 2014
Start date June 2011
Est. completion date March 2013

Study information

Verified date December 2014
Source Neodyne Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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 minimize scar formation in a simple manner.


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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date March 2013
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
embrace device
Adhesive bandage/dressing intended to minimize scar formation.

Locations

Country Name City State
United States Academy of Clinical Research Arlington Texas
United States Atherton Plastic Surgery Atherton California
United States Vipul R. Dev MD Bakersfield California
United States The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery Dallas Texas
United States Elite MD Danville California
United States Kaufman and Clark Plastic Surgery Folsom California
United States US Army Institute of Surgical Research Fort Sam Houston Texas
United States The Aesthetic Institute Fullerton California
United States The Korman Group Mountain View California
United States Newport Plastic Surgery Newport Beach California
United States Lauren Greenberg, MD Palo Alto California
United States Plastic Surgery Associates of Santa Rose Santa Rosa California
United States Joseph Mele, MD Walnut Creek California

Sponsors (2)

Lead Sponsor Collaborator
Neodyne Biosciences, Inc. U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analogue Scale (VAS) 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.
12 months No
Secondary Subject and Investigator Satisfaction With the Aesthetic Results Up to 12 months No
Secondary Ease of Use Up to 12 months No
Secondary Comfort Level Related to Study Device Application, Wear and Removal Up to 12 weeks No
Secondary Comparison of Scar Smoothness of Treated Side as Compared to the Control Side Up to 12 months No
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