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OpenTrials
Completed

NCT Number: NCT00766727

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

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.

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Key information

Conditions

Post Surgical Incisions From Abdominoplasty Procedures Surgical Wound Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Josh Korman, MD

Mountain View, California, 94040, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLYDe Dressing

Device

Wound dressing intended to minimize scar formation

Primary outcomes

  1. Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)

    Time frame: through 12 months

    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.

Sponsors and collaborators

Lead sponsor

Neodyne Biosciences, Inc.

Industry

Registry information

Acronym: Mona Lisa

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 6, 2008
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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