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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2008 by Rosalind Franklin University of Medicine and Science.
Recruitment status was Recruiting

Sponsor:

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

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 Endpoint Classification: Efficacy Study 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:

Drug Information available for: Sulfadiazine Sulfadiazine, silver

U.S. FDA Resources

Further study details as provided by Rosalind Franklin University of Medicine and Science:

Primary Outcome Measures:

time to healing [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

time to return to regular shoe gear [ Time Frame: weekly ] [ Designated as safety issue: No ]
days unable to work [ Time Frame: weekly ] [ Designated as safety issue: No ]


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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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
Health Authority:	United States: Institutional Review Board

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 September 27, 2016

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