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

Condition(s) targeted: Ingrown Nail

Intervention: oxidized regenerated cellulose collagen-silver (Device); topical silver sulfadiazine cream (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Rosalind Franklin University of Medicine and Science

Official(s) and/or principal investigator(s):
David G Armstrong, DPM, PhD, Principal Investigator, Affiliation: Rosalind Franklin University

Overall contact:
David G Armstrong, DPM, PhD, Phone: 847-578-8440, Email: david.armstrong@rosalindfranklin.edu

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.

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

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

Primary outcome: time to healing

Secondary outcome:

time to return to regular shoe gear

days unable to work

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

David G Armstrong, DPM, PhD, Phone: 847-578-8440, Email: david.armstrong@rosalindfranklin.edu

Scholl Foot and Ankle Center, North Chicago, Illinois 60064, United States; Recruiting
Ryan T Crews, MS, Phone: 847-578-8437, Email: ryan.crews@rosalindfranklin.edu
David Armstrong, DPM, PhD, Principal Investigator
Stephanie Wu, DPM, MS, Sub-Investigator
James Wrobel, DPM, MS, Sub-Investigator

Preofessional Education and Research Institutue, Roanoke, Virginia 24016, United States; Recruiting
Charles Zelen, DPM, Phone: 540-725-5027, Email: cmzelen@periedu.com
Charles Zelen, DPM, Principal Investigator

Starting date: November 2005
Last updated: March 18, 2008