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

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ClinicalTrials.gov Identifier: NCT00641433
Recruitment Status : Unknown
Verified March 2008 by Rosalind Franklin University of Medicine and Science.
Recruitment status was:  Recruiting
First Posted : March 24, 2008
Last Update Posted : March 24, 2008
Sponsor:
Information provided by:
Rosalind Franklin University of Medicine and Science

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ingrown Nail Device: oxidized regenerated cellulose collagen-silver Drug: topical silver sulfadiazine cream Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Collagen-Silver Versus Standard Care Following Phenol Ablation of Ingrown Nails: A Randomized Controlled Trial
Study Start Date : November 2005
Estimated Primary Completion Date : May 2008
Estimated Study Completion Date : May 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: experimental
Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.
 Device: oxidized regenerated cellulose collagen-silver
Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.
Other Name: Prisma
Active Comparator: Control
Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.
 Drug: topical silver sulfadiazine cream
Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.
Other Name: Silvadene, Thermazene


Outcome Measures
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Primary Outcome Measures :
  1. time to healing [ Time Frame: weekly ]

Secondary Outcome Measures :
  1. time to return to regular shoe gear [ Time Frame: weekly ]
  2. days unable to work [ Time Frame: weekly ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641433


Contacts
Contact: David G Armstrong, DPM, PhD 847-578-8440 david.armstrong@rosalindfranklin.edu

Locations
United States, Illinois
Scholl Foot and Ankle Center Recruiting
North Chicago, Illinois, United States, 60064
Contact: Ryan T Crews, MS    847-578-8437    ryan.crews@rosalindfranklin.edu   
Principal Investigator: David Armstrong, DPM, PhD         
Sub-Investigator: Stephanie Wu, DPM, MS         
Sub-Investigator: James Wrobel, DPM, MS         
United States, Virginia
Preofessional Education and Research Institutue Recruiting
Roanoke, Virginia, United States, 24016
Contact: Charles Zelen, DPM    540-725-5027    cmzelen@periedu.com   
Principal Investigator: Charles Zelen, DPM         
Sponsors and Collaborators
Rosalind Franklin University of Medicine and Science
Investigators
Principal Investigator: David G Armstrong, DPM, PhD Rosalind Franklin University
More Information
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Responsible Party: Office of Sponsored Research, Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00641433     History of Changes
Other Study ID Numbers: ORT 014
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: March 24, 2008
Last Verified: March 2008

Keywords provided by Rosalind Franklin University of Medicine and Science:
chemocautery

Additional relevant MeSH terms:
Nails, Ingrown
Nail Diseases
Skin Diseases
Sulfadiazine
Silver Sulfadiazine
 Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Anti-Infective Agents, Local