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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Rosalind Franklin University of Medicine and Science.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00641433
First received: March 18, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted

March 18, 2008
March 18, 2008
November 2005
May 2008   (final data collection date for primary outcome measure)
time to healing [ Time Frame: weekly ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • time to return to regular shoe gear [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • days unable to work [ Time Frame: weekly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails
Topical Collagen-Silver Versus Standard Care Following Phenol Ablation of Ingrown Nails: A Randomized Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Ingrown Nail
  • Device: oxidized regenerated cellulose collagen-silver
    Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.
    Other Name: Prisma
  • Drug: topical silver sulfadiazine cream
    Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.
    Other Name: Silvadene, Thermazene
  • Experimental: experimental
    Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.
    Intervention: Device: oxidized regenerated cellulose collagen-silver
  • Active Comparator: Control
    Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.
    Intervention: Drug: topical silver sulfadiazine cream
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: David G Armstrong, DPM, PhD 847-578-8440 david.armstrong@rosalindfranklin.edu
United States
 
NCT00641433
ORT 014
No
Office of Sponsored Research, Rosalind Franklin University of Medicine and Science
Rosalind Franklin University of Medicine and Science
Not Provided
Principal Investigator: David G Armstrong, DPM, PhD Rosalind Franklin University
Rosalind Franklin University of Medicine and Science
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP