Clinical trial NCT01399099: A Study of a Novel Silicone Dressing to Minimize Scar Formation
Official title: Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic
Keywords: scar
incision
wound healing
scarring
post-surgical
Lead sponsor: Neodyne Biosciences, Inc.
Sponsor class: INDUSTRY
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2011-07-21
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 minimize scar formation in a simple manner.

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 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.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 12 months
measure: Visual Analogue Scale (VAS)
timeFrame: 6 months
Secondary outcomes:
measure: Patient and Observer Scar Assessment Scale (POSAS) - Patient Results
timeFrame: 6 Months
measure: Patient and Observer Scar Assessment Scale (POSAS) - Patient Results
timeFrame: 12 Months
measure: Patient and Observer Scar Assessment Scale (POSAS) - Observer Results
timeFrame: 6 Months
measure: Patient and Observer Scar Assessment Scale (POSAS) - Observer Results
timeFrame: 12 Months
measure: Patient Satisfaction - Scar Minimization
timeFrame: 6 Months
measure: Patient Satisfaction - Recommend
timeFrame: 6 Months
measure: Patient Satisfaction - Use Again
timeFrame: 6 Months
measure: Patient Satisfaction - Scar Minimization
timeFrame: 12 Months
measure: Patient Satisfaction - Recommend
timeFrame: 12 Months
measure: Patient Satisfaction - Use Again
timeFrame: 12 Months
Other outcomes:
Locations:
city: Atherton
country: United States
facility: Atherton Plastic Surgery
state: California
city: Bakersfield
country: United States
facility: Vipul R. Dev MD
state: California
city: Danville
country: United States
facility: Elite MD
state: California
city: Folsom
country: United States
facility: Kaufman and Clark Plastic Surgery
state: California
city: Fullerton
country: United States
facility: The Aesthetic Institute
state: California
city: Mountain View
country: United States
facility: The Korman Group
state: California
city: Newport Beach
country: United States
facility: Newport Plastic Surgery
state: California
city: Palo Alto
country: United States
facility: Lauren Greenberg, MD
state: California
city: Santa Rosa
country: United States
facility: Plastic Surgery Associates of Santa Rose
state: California
city: Walnut Creek
country: United States
facility: Joseph Mele, MD
state: California
city: Arlington
country: United States
facility: Academy of Clinical Research
state: Texas
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery
state: Texas
city: Fort Sam Houston
country: United States
facility: US Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Rodney J Rohrich, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Longaker MT, Rohrich RJ, Greenberg L, Furnas H, Wald R, Bansal V, Seify H, Tran A, Weston J, Korman JM, Chan R, Kaufman D, Dev VR, Mele JA, Januszyk M, Cowley C, McLaughlin P, Beasley B, Gurtner GC. A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation. Plast Reconstr Surg. 2014 Sep;134(3):536-546. doi: 10.1097/PRS.0000000000000417.