Trial | NCT00641433  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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.
Study Started
Nov 30
2005
Primary Completion
May 31
2008
Anticipated
Study Completion
May 31
2008
Anticipated
Last Update
Mar 24
2008
Estimate

Device oxidized regenerated cellulose collagen-silver

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

  • Other names: Prisma

Drug topical silver sulfadiazine cream

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

  • Other names: Silvadene, Thermazene

experimental Experimental

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

Control Active Comparator

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

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
No Results Posted