Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Rosalind Franklin University of Medicine and Science.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Rosalind Franklin University of Medicine and Science
Information provided by:
Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00641433
First received: March 18, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ingrown Nail |
Device: oxidized regenerated cellulose collagen-silver Drug: topical silver sulfadiazine cream |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Topical Collagen-Silver Versus Standard Care Following Phenol Ablation of Ingrown Nails: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Rosalind Franklin University of Medicine and Science:
Primary Outcome Measures:
- time to healing [ Time Frame: weekly ]
Secondary Outcome Measures:
- time to return to regular shoe gear [ Time Frame: weekly ]
- days unable to work [ Time Frame: weekly ]
| Estimated Enrollment: | 80 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | May 2008 |
| Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: experimental
Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.
|
Device: oxidized regenerated cellulose collagen-silver
Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.
Other Name: Prisma
|
|
Active Comparator: Control
Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.
|
Drug: topical silver sulfadiazine cream
Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.
Other Name: Silvadene, Thermazene
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641433
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641433
Contacts
| Contact: David G Armstrong, DPM, PhD | 847-578-8440 | david.armstrong@rosalindfranklin.edu |
Locations
| 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 | |
Sponsors and Collaborators
Rosalind Franklin University of Medicine and Science
Investigators
| Principal Investigator: | David G Armstrong, DPM, PhD | Rosalind Franklin University |
More Information
| 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 |
| Study First Received: | March 18, 2008 |
| Last Updated: | March 18, 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 |
ClinicalTrials.gov processed this record on May 25, 2017