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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs. |
|
| Control | Active Comparator | Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxidized regenerated cellulose collagen-silver | Device | Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix. |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to healing | weekly |
| Measure | Description | Time Frame |
|---|---|---|
| time to return to regular shoe gear | weekly | |
| days unable to work | weekly |
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Inclusion Criteria:
Exclusion Criteria:
Patients with immunocompromised states
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David G Armstrong, DPM, PhD | Contact | 847-578-8440 | david.armstrong@rosalindfranklin.edu |
| Name | Affiliation | Role |
|---|---|---|
| David G Armstrong, DPM, PhD | Rosalind Franklin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scholl Foot and Ankle Center | Recruiting | North Chicago | Illinois | 60064 | United States |
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| ID | Term |
|---|---|
| D009263 | Nails, Ingrown |
| ID | Term |
|---|---|
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D012837 | Silver Sulfadiazine |
| ID | Term |
|---|---|
| D013411 | Sulfadiazine |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
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| topical silver sulfadiazine cream | Drug | Cream will be applied to nailbed daily and dressed with a bandage until healing occurs. |
|
|
| Preofessional Education and Research Institutue | Recruiting | Roanoke | Virginia | 24016 | United States |
|
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |