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

NCT ID: NCT00766727

Last Updated: 2020-12-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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.

Conditions

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Post Surgical Incisions From Abdominoplasty Procedures

Keywords

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incision abdominoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GLYDe Dressing

Investigational Dressing

Group Type EXPERIMENTAL

GLYDe Dressing

Intervention Type DEVICE

Wound dressing intended to minimize scar formation

Standard of Care

Standard of care comparator

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GLYDe Dressing

Wound dressing intended to minimize scar formation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neodyne Biosciences, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Longaker, MD

Role: STUDY_DIRECTOR

Neodyne Biosciences, Inc.

Locations

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Josh Korman, MD

Mountain View, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21606834 (View on PubMed)

Other Identifiers

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CA001

Identifier Type: -

Identifier Source: org_study_id