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Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE) (IMPROVE)

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 prevention trial for Hypertrophic focused on measuring scar, incision, wound healing, scarring, scar revision

Eligibility Criteria

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

Inclusion Criteria:

  • The scar to be revised is:

    • at least 12 months old
    • linear and suitable for revision by excision and direct closure
    • appropriate size and location for Neodyne Dressing

  • The subject:

    • age > 18 and < 65 years old

Exclusion Criteria:

  • Subjects with a skin disorder that is chronic or currently active.
  • Subjects who are involved in ongoing litigation in connection with the scar to be revised.
  • Subjects with a history of collagen vascular disease
  • Subjects diagnosed with scleroderma
  • Subject who currently smokes
  • 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.

Sites / Locations

  • Duet Plastic Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Study Participants

Arm Description

Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her 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
September 6, 2011
Last Updated
November 21, 2014
Sponsor
Neodyne Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01430130
Brief Title
Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)
Acronym
IMPROVE
Official Title
Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neodyne Biosciences, Inc.

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 the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term 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, scar revision

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
All Study Participants
Arm Type
Experimental
Arm Description
Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Intervention Type
Device
Intervention Name(s)
embrace device
Other Intervention Name(s)
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
6 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: The scar to be revised is: at least 12 months old linear and suitable for revision by excision and direct closure appropriate size and location for Neodyne Dressing The subject: age > 18 and < 65 years old Exclusion Criteria: Subjects with a skin disorder that is chronic or currently active. Subjects who are involved in ongoing litigation in connection with the scar to be revised. Subjects with a history of collagen vascular disease Subjects diagnosed with scleroderma Subject who currently smokes 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Weintraub, MD
Organizational Affiliation
Duet Plastic Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angeline Lim, MD
Organizational Affiliation
Duet Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duet Plastic Surgery
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)

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