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Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care (Mona Lisa)

Primary Purpose

Post Surgical Incisions From Abdominoplasty Procedures

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

About this trial

This is an interventional treatment trial for Post Surgical Incisions From Abdominoplasty Procedures focused on measuring incision, abdominoplasty

Eligibility Criteria

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

Inclusion Criteria:

  • subjects who have undergone an abdominoplasty 1 week prior to study participation

Exclusion Criteria:

  • subjects with a history of collagen vascular disease or scleroderma
  • subjects with known adverse reactions to steri-strips, medical tapes or adhesives

Sites / Locations

  • Josh Korman, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GLYDe Dressing

Standard of Care

Arm Description

Investigational Dressing

Standard of care comparator

Outcomes

Primary Outcome Measures

Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)
Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels. A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2008
Last Updated
December 11, 2020
Sponsor
Neodyne Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00766727
Brief Title
Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
Acronym
Mona Lisa
Official Title
Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.
Detailed Description
This study will evaluate a new dressing in up to 30 patients who have undergone an abdominoplasty procedure. They will wear the dressing through 8 weeks post surgery and the scar will be evaluated at 3 months post surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Surgical Incisions From Abdominoplasty Procedures
Keywords
incision, abdominoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLYDe Dressing
Arm Type
Experimental
Arm Description
Investigational Dressing
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care comparator
Intervention Type
Device
Intervention Name(s)
GLYDe Dressing
Intervention Description
Wound dressing intended to minimize scar formation
Primary Outcome Measure Information:
Title
Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)
Description
Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels. A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint.
Time Frame
through 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 an abdominoplasty 1 week prior to study participation Exclusion Criteria: subjects with a history of collagen vascular disease or scleroderma subjects with known adverse reactions to steri-strips, medical tapes or adhesives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Longaker, MD
Organizational Affiliation
Neodyne Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Josh Korman, MD
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21606834
Citation
Gurtner GC, Dauskardt RH, Wong VW, Bhatt KA, Wu K, Vial IN, Padois K, Korman JM, Longaker MT. Improving cutaneous scar formation by controlling the mechanical environment: large animal and phase I studies. Ann Surg. 2011 Aug;254(2):217-25. doi: 10.1097/SLA.0b013e318220b159.
Results Reference
derived

Learn more about this trial

Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care

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