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Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)

NCT ID: NCT01430130

Last Updated: 2014-11-28

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

2011-09-30

Study Completion Date

2012-11-30

Brief Summary

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Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.

Detailed Description

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It is proposed to study a dressing designed to reduce the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.

Conditions

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Hypertrophic

Keywords

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scar incision wound healing scarring scar revision

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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All Study Participants

Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.

Group Type EXPERIMENTAL

embrace device

Intervention Type DEVICE

Adhesive bandage/dressing intended to minimize scar formation.

Interventions

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embrace device

Adhesive bandage/dressing intended to minimize scar formation.

Intervention Type DEVICE

Other Intervention Names

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Neodyne dressing

Eligibility Criteria

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Inclusion Criteria

* The scar to be revised is:

* at least 12 months old
* linear and suitable for revision by excision and direct closure
* appropriate size and location for Neodyne Dressing
* The subject:

* age \> 18 and \< 65 years old

Exclusion Criteria

* Subjects with a skin disorder that is chronic or currently active.
* Subjects who are involved in ongoing litigation in connection with the scar to be revised.
* Subjects with a history of collagen vascular disease
* Subjects diagnosed with scleroderma
* Subject who currently smokes
* Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives
* Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
* Subjects with inability to maintain adequate care of incision.
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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Jennifer Weintraub, MD

Role: PRINCIPAL_INVESTIGATOR

Duet Plastic Surgery

Angeline Lim, MD

Role: PRINCIPAL_INVESTIGATOR

Duet Plastic Surgery

Locations

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Duet Plastic Surgery

Palo Alto, California, United States

Site Status

Countries

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United States

Other Identifiers

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CA005

Identifier Type: -

Identifier Source: org_study_id