Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails
Primary Purpose
Ingrown Nail
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
oxidized regenerated cellulose collagen-silver
topical silver sulfadiazine cream
Sponsored by
About this trial
This is an interventional treatment trial for Ingrown Nail focused on measuring chemocautery
Eligibility 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
Sites / Locations
- Scholl Foot and Ankle CenterRecruiting
- Preofessional Education and Research InstitutueRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental
Control
Arm Description
Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.
Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.
Outcomes
Primary Outcome Measures
time to healing
Secondary Outcome Measures
time to return to regular shoe gear
days unable to work
Full Information
NCT ID
NCT00641433
First Posted
March 18, 2008
Last Updated
March 18, 2008
Sponsor
Rosalind Franklin University of Medicine and Science
1. Study Identification
Unique Protocol Identification Number
NCT00641433
Brief Title
Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails
Official Title
Topical Collagen-Silver Versus Standard Care Following Phenol Ablation of Ingrown Nails: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
May 2008 (Anticipated)
Study Completion Date
May 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Rosalind Franklin University of Medicine and Science
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ingrown Nail
Keywords
chemocautery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental
Arm Type
Experimental
Arm Description
Subjects will daily dress their nail bed with oxidized regenerated cellulose collagen-silver, until healing occurs.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Topical silver sulfadiazine cream will be applied daily to the wound bed until healing has occured.
Intervention Type
Device
Intervention Name(s)
oxidized regenerated cellulose collagen-silver
Other Intervention Name(s)
Prisma
Intervention Description
Wound dressed daily with oxidized regenerated cellulose collagen-silver matrix.
Intervention Type
Drug
Intervention Name(s)
topical silver sulfadiazine cream
Other Intervention Name(s)
Silvadene, Thermazene
Intervention Description
Cream will be applied to nailbed daily and dressed with a bandage until healing occurs.
Primary Outcome Measure Information:
Title
time to healing
Time Frame
weekly
Secondary Outcome Measure Information:
Title
time to return to regular shoe gear
Time Frame
weekly
Title
days unable to work
Time Frame
weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David G Armstrong, DPM, PhD
Phone
847-578-8440
Email
david.armstrong@rosalindfranklin.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Armstrong, DPM, PhD
Organizational Affiliation
Rosalind Franklin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scholl Foot and Ankle Center
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan T Crews, MS
Phone
847-578-8437
Email
ryan.crews@rosalindfranklin.edu
First Name & Middle Initial & Last Name & Degree
David Armstrong, DPM, PhD
First Name & Middle Initial & Last Name & Degree
Stephanie Wu, DPM, MS
First Name & Middle Initial & Last Name & Degree
James Wrobel, DPM, MS
Facility Name
Preofessional Education and Research Institutue
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Zelen, DPM
Phone
540-725-5027
Email
cmzelen@periedu.com
First Name & Middle Initial & Last Name & Degree
Charles Zelen, DPM
12. IPD Sharing Statement
Learn more about this trial
Topical Collagen-Silver Versus Standard Care Following Removal of Ingrown Nails
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