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A Study of a Novel Silicone Dressing to Minimize Scar Formation (REFINE)

Primary Purpose

Hypertrophic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
embrace device
Sponsored by
Neodyne Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic focused on measuring scar, incision, wound healing, scarring, post-surgical

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atherton Plastic Surgery
  • Vipul R. Dev MD
  • Elite MD
  • Kaufman and Clark Plastic Surgery
  • The Aesthetic Institute
  • The Korman Group
  • Newport Plastic Surgery
  • Lauren Greenberg, MD
  • Plastic Surgery Associates of Santa Rose
  • Joseph Mele, MD
  • Academy of Clinical Research
  • The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery
  • US Army Institute of Surgical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Study Participants

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Subject and Investigator Satisfaction With the Aesthetic Results
Ease of Use
Comfort Level Related to Study Device Application, Wear and Removal
Comparison of Scar Smoothness of Treated Side as Compared to the Control Side

Full Information

First Posted
June 27, 2011
Last Updated
December 17, 2014
Sponsor
Neodyne Biosciences, Inc.
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01399099
Brief Title
A Study of a Novel Silicone Dressing to Minimize Scar Formation
Acronym
REFINE
Official Title
Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neodyne Biosciences, Inc.
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic
Keywords
scar, incision, wound healing, scarring, post-surgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Study Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
embrace device
Other Intervention Name(s)
Neodyne Device, embrace dressing, Neodyne Dressing
Intervention Description
Adhesive bandage/dressing intended to minimize scar formation.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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
Secondary Outcome Measure Information:
Title
Subject and Investigator Satisfaction With the Aesthetic Results
Time Frame
Up to 12 months
Title
Ease of Use
Time Frame
Up to 12 months
Title
Comfort Level Related to Study Device Application, Wear and Removal
Time Frame
Up to 12 weeks
Title
Comparison of Scar Smoothness of Treated Side as Compared to the Control Side
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodney J Rohrich, MD, FACS
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atherton Plastic Surgery
City
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States
Facility Name
Vipul R. Dev MD
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Facility Name
Elite MD
City
Danville
State/Province
California
ZIP/Postal Code
94526
Country
United States
Facility Name
Kaufman and Clark Plastic Surgery
City
Folsom
State/Province
California
ZIP/Postal Code
95630
Country
United States
Facility Name
The Aesthetic Institute
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
The Korman Group
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Newport Plastic Surgery
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Lauren Greenberg, MD
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Plastic Surgery Associates of Santa Rose
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95409
Country
United States
Facility Name
Joseph Mele, MD
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Academy of Clinical Research
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
The University of Texas Southwestern Medical Center - Dept. of Plastic Surgery
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9132
Country
United States
Facility Name
US Army Institute of Surgical Research
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24804638
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.
Results Reference
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A Study of a Novel Silicone Dressing to Minimize Scar Formation

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