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

Rosalind Franklin University of Medicine and Science

Status: Unknown

Conditions: Ingrown Nail

Treatments: Drug: topical silver sulfadiazine cream; Device: oxidized regenerated cellulose collagen-silver

Study type: Interventional

Funder types: Other

Identifiers

NCT00641433

ORT 014

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

experimental

Experimental group

Description:

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

Treatment:

Device: oxidized regenerated cellulose collagen-silver

Control

Active Comparator group

Description:

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

Treatment:

Drug: topical silver sulfadiazine cream