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

Not Applicable

• Conditions: Ingrown Nail
• Interventions: Device: oxidized regenerated cellulose collagen-silver; Drug: topical silver sulfadiazine cream

• Registration Number: NCT00641433
• Lead Sponsor: Rosalind Franklin University of Medicine and Science

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Status Verified: 2008-03
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-18
• Last Update Submitted: 2008-03-18
• Study First Posted: 2008-03-24
• Last Update Posted: 2008-03-24
• Primary Completion: 2008-05
• Study Completion: 2008-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	oxidized regenerated cellulose collagen-silver	Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.
Control	topical silver sulfadiazine cream	Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.

Primary Outcome Measures

Name	Time	Method
time to healing	weekly

Secondary Outcome Measures

Name	Time	Method
time to return to regular shoe gear	weekly
days unable to work	weekly

Trial Locations

Locations (2)

Scholl Foot and Ankle Center; 🇺🇸 North Chicago, Illinois, United States

Preofessional Education and Research Institutue; 🇺🇸 Roanoke, Virginia, United States