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

Ingrown Nail Clinical Trial

Official title:

Topical Collagen-Silver Versus Standard Care Following Phenol Ablation of Ingrown Nails: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00641433
• Other study ID #: ORT 014
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2008
• Last updated: March 18, 2008
• Start date: November 2005
• Est. completion date: May 2008

Study information

• Verified date: March 2008
• Source: Rosalind Franklin University of Medicine and Science
• Contact: David G Armstrong, DPM, PhD
• Phone: 847-578-8440
• Email: david.armstrong[@]rosalindfranklin.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ingrown Nail
• Nails, Ingrown

Intervention

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

Drug:
• topical silver sulfadiazine cream
Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.

Locations

Country	Name	City	State
United States	Scholl Foot and Ankle Center	North Chicago	Illinois
United States	Preofessional Education and Research Institutue	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Rosalind Franklin University of Medicine and Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to healing		weekly	No
Secondary	time to return to regular shoe gear		weekly	No
Secondary	days unable to work		weekly	No