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

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

Conditions
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Ingrown Nail

Intervention / Treatment
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* Device: oxidized regenerated cellulose collagen-silver
* Drug: topical silver sulfadiazine cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs. | Device: oxidized regenerated cellulose collagen-silver<br>* Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.<br>* Other names: Prisma;|
| Active Comparator: Control<br>Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured. | Drug: topical silver sulfadiazine cream<br>* Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.<br>* Other names: Silvadene, Thermazene;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to healing |  | weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to return to regular shoe gear |  | weekly | 
| days unable to work |  | weekly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemocautery