A Study of a Novel Silicone Dressing to Minimize Scar Formation

Not Applicable

Completed

Conditions: Hypertrophic

Interventions: Device: embrace device

Registration Number: NCT01399099

Lead Sponsor: Neodyne Biosciences, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 67

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Study Participants	embrace device	Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator's standard of care. Participant served as his own control.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction - Recommend	12 Months	Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.
Patient Satisfaction - Use Again	12 Months	Subjects were asked if they were to have another procedure that would leave a scar how likely would they be to use embrace treatment again.
Patient and Observer Scar Assessment Scale (POSAS) - Patient Results	12 Months	The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively \[1\]. The POSAS criteria evaluated by the patients in this study were pain, itching, color, stiffness, thickness, irregularity, and overall opinion. \[1\] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.
Patient and Observer Scar Assessment Scale (POSAS) - Observer Results	12 Months	The Patient and Observer Scar Assessment Scale consists of two numeric scales: the Patient Scar Assessment Scale (patient scale) and the Observer Scar Assessment Scale (observer scale). The patient and observer scales have to be completed by the patient and the observer, respectively \[1\]. The POSAS criteria evaluated by the observers in this study were vascularity, pigmentation, thickness, relief, pliability, surface area, and an overall opinion. \[1\] Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56. PMID: 15253184.
Patient Satisfaction - Scar Minimization	12 Months	Subjects were were asked to compare the embrace-treated side with the control-treated side with regards to their satisfaction with the scar minimization on their incision.

Trial Locations

Locations (13): Elite MD
🇺🇸
Danville, California, United States
Newport Plastic Surgery
🇺🇸
Newport Beach, California, United States
Atherton Plastic Surgery
🇺🇸
Atherton, California, United States
Kaufman and Clark Plastic Surgery
🇺🇸
Folsom, California, United States
The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery
🇺🇸
Dallas, Texas, United States
Vipul R. Dev MD
🇺🇸
Bakersfield, California, United States
Joseph Mele, MD
🇺🇸
Walnut Creek, California, United States
Plastic Surgery Associates of Santa Rose
🇺🇸
Santa Rosa, California, United States
The Aesthetic Institute
🇺🇸
Fullerton, California, United States
The Korman Group
🇺🇸
Mountain View, California, United States
Lauren Greenberg, MD
🇺🇸
Palo Alto, California, United States
Academy of Clinical Research
🇺🇸
Arlington, Texas, United States
US Army Institute of Surgical Research
🇺🇸
Fort Sam Houston, Texas, United States