Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails
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ClinicalTrials.gov Identifier: NCT00641433 |
Recruitment Status
: Unknown
Verified March 2008 by Rosalind Franklin University of Medicine and Science.
Recruitment status was: Recruiting
First Posted
: March 24, 2008
Last Update Posted
: March 24, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ingrown Nail | Device: oxidized regenerated cellulose collagen-silver Drug: topical silver sulfadiazine cream | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Topical Collagen-Silver Versus Standard Care Following Phenol Ablation of Ingrown Nails: A Randomized Controlled Trial |
Study Start Date : | November 2005 |
Estimated Primary Completion Date : | May 2008 |
Estimated Study Completion Date : | May 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: experimental
Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.
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Device: oxidized regenerated cellulose collagen-silver
Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.
Other Name: Prisma
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Active Comparator: Control
Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.
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Drug: topical silver sulfadiazine cream
Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.
Other Name: Silvadene, Thermazene
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- time to healing [ Time Frame: weekly ]
- time to return to regular shoe gear [ Time Frame: weekly ]
- days unable to work [ Time Frame: weekly ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641433
Contact: David G Armstrong, DPM, PhD | 847-578-8440 | david.armstrong@rosalindfranklin.edu |
United States, Illinois | |
Scholl Foot and Ankle Center | Recruiting |
North Chicago, Illinois, United States, 60064 | |
Contact: Ryan T Crews, MS 847-578-8437 ryan.crews@rosalindfranklin.edu | |
Principal Investigator: David Armstrong, DPM, PhD | |
Sub-Investigator: Stephanie Wu, DPM, MS | |
Sub-Investigator: James Wrobel, DPM, MS | |
United States, Virginia | |
Preofessional Education and Research Institutue | Recruiting |
Roanoke, Virginia, United States, 24016 | |
Contact: Charles Zelen, DPM 540-725-5027 cmzelen@periedu.com | |
Principal Investigator: Charles Zelen, DPM |
Principal Investigator: | David G Armstrong, DPM, PhD | Rosalind Franklin University |
Responsible Party: | Office of Sponsored Research, Rosalind Franklin University of Medicine and Science |
ClinicalTrials.gov Identifier: | NCT00641433 History of Changes |
Other Study ID Numbers: |
ORT 014 |
First Posted: | March 24, 2008 Key Record Dates |
Last Update Posted: | March 24, 2008 |
Last Verified: | March 2008 |
Keywords provided by Rosalind Franklin University of Medicine and Science:
chemocautery |
Additional relevant MeSH terms:
Nails, Ingrown Nail Diseases Skin Diseases Sulfadiazine Silver Sulfadiazine |
Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents Coccidiostats Anti-Infective Agents, Local |