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

Post Surgical Incisions From Abdominoplasty Procedures Clinical Trial

— Mona Lisa  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766727
• Other study ID #: CA001
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: March 2010

Study information

• Verified date: December 2020
• Source: Neodyne Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Surgical Incisions From Abdominoplasty Procedures
• Surgical Wound

Intervention

Device:
• GLYDe Dressing
Wound dressing intended to minimize scar formation

Locations

Country	Name	City	State
United States	Josh Korman, MD	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Neodyne Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through 12 months