A Study of a Novel Silicone Dressing to Minimize Scar Formation

Neodyne Biosciences, Inc.67 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertrophic

Interventions

embrace deviceDEVICE

Adhesive bandage/dressing intended to minimize scar formation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (13)

Atherton Plastic Surgery

Atherton, California, United States

Vipul R. Dev MD

Bakersfield, California, United States

Elite MD

Danville, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Visual Analogue Scale (VAS)

Time frame: 6 months

Secondary Outcomes

Patient and Observer Scar Assessment Scale (POSAS) - Patient Results

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. The Patient and Observer Scar Assessment Scale (POSAS) ranges from 1 to 10 with 10 being the worst imaginable or most different. \[1\] 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.

Data from ClinicalTrials.gov

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Kaufman and Clark Plastic Surgery

Folsom, California, 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, United States

...and 3 more locations

Time frame: 6 Months

Patient and Observer Scar Assessment Scale (POSAS) - Patient Results

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.

Time frame: 12 Months

Patient and Observer Scar Assessment Scale (POSAS) - Observer Results

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.

Time frame: 6 Months

Patient and Observer Scar Assessment Scale (POSAS) - Observer Results

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.

Time frame: 12 Months

Patient Satisfaction - Scar Minimization

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.

Time frame: 6 Months

Patient Satisfaction - Recommend

Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.

Time frame: 6 Months

Patient Satisfaction - Use Again

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.

Time frame: 6 Months

Patient Satisfaction - Scar Minimization

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.

Time frame: 12 Months

Patient Satisfaction - Recommend

Subjects were were asked to rate how likely they were to recommend embrace treatment to a friend.

Time frame: 12 Months

Patient Satisfaction - Use Again

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.

Time frame: 12 Months