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Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails

NCT ID: NCT00641433

Last Updated: 2008-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-05-31

Brief Summary

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This study's purpose is to prospectively determine whether topical therapy with an oxidized regenerated cellulose collagen-silver compound is more effective than the current standard of topical antibiotic therapy for care following the removal of an ingrown toenail. Eighty adult patients with ingrown toenails will be recruited. Each patient will randomly be assigned to apply either topical silver sulfadiazine cream (standard antibiotic) or the novel collagen-silver compound to their nail bed daily, following removal of the ingrown portion of nail. Patients will return for follow up visits weekly, until healing has occurred or twelve weeks have passed. Healing will be defined as resolution of drainage and inflammatory changes surrounding the nail border.

Detailed Description

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Conditions

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Ingrown Nail

Keywords

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chemocautery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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experimental

Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.

Group Type EXPERIMENTAL

oxidized regenerated cellulose collagen-silver

Intervention Type DEVICE

Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.

Control

Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.

Group Type ACTIVE_COMPARATOR

topical silver sulfadiazine cream

Intervention Type DRUG

Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.

Interventions

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oxidized regenerated cellulose collagen-silver

Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.

Intervention Type DEVICE

topical silver sulfadiazine cream

Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.

Intervention Type DRUG

Other Intervention Names

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Prisma Silvadene, Thermazene

Eligibility Criteria

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Inclusion Criteria

* Ingrown toenails will be defined as any incurvated nail border that digs into the skin of the nail fold and causes pain and discomfort

Exclusion Criteria

* Patients with immunocompromised states

* chronic steroid use
* diabetes mellitus
* collagen vascular disease
* HIV infection
* Cellulitis proximal to the hallux interphalangeal joint or peripheral vascular disease will be excluded
* We will define peripheral vascular disease as the absence of one or more pedal pulses or the presence of dystrophic changes to the integument
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rosalind Franklin University of Medicine and Science

OTHER

Sponsor Role lead

Responsible Party

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Rosalind Franklin University of Medicine and Science

Principal Investigators

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David G Armstrong, DPM, PhD

Role: PRINCIPAL_INVESTIGATOR

Rosalind Franklin University

Locations

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Scholl Foot and Ankle Center

North Chicago, Illinois, United States

Site Status RECRUITING

Preofessional Education and Research Institutue

Roanoke, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David G Armstrong, DPM, PhD

Role: CONTACT

Phone: 847-578-8440

Email: [email protected]

Facility Contacts

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Ryan T Crews, MS

Role: primary

Charles Zelen, DPM

Role: primary

Other Identifiers

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ORT 014

Identifier Type: -

Identifier Source: org_study_id