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

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.

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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

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