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

Neodyne Biosciences, Inc.12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post Surgical Incisions From Abdominoplasty Procedures

Interventions

GLYDe DressingDEVICE

Wound 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 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

Locations (1)

Josh Korman, MD

Mountain View, California, United States

Outcomes

Primary Outcomes

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.

Time frame: through 12 months

Data from ClinicalTrials.gov

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