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

March 18, 2008 updated by: Rosalind Franklin University of Medicine and Science

Topical Collagen-Silver Versus Standard Care Following Phenol Ablation of Ingrown Nails: A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • North Chicago, Illinois, United States, 60064
        • Recruiting
        • Scholl Foot and Ankle Center
        • Contact:
        • Principal Investigator:
          • David Armstrong, DPM, PhD
        • Sub-Investigator:
          • Stephanie Wu, DPM, MS
        • Sub-Investigator:
          • James Wrobel, DPM, MS
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Recruiting
        • Preofessional Education and Research Institutue
        • Contact:
        • Principal Investigator:
          • Charles Zelen, DPM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Silvadene, Thermazene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time to healing
Time Frame: weekly
weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
time to return to regular shoe gear
Time Frame: weekly
weekly
days unable to work
Time Frame: weekly
weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rosalind Franklin University of Medicine and Science

Investigators

  • Principal Investigator: David G Armstrong, DPM, PhD, Rosalind Franklin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Anticipated)

May 1, 2008

Study Completion (Anticipated)

May 1, 2008

Study Registration Dates

First Submitted

March 18, 2008

First Submitted That Met QC Criteria

March 18, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

March 24, 2008

Last Update Submitted That Met QC Criteria

March 18, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORT 014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ingrown Nail

Clinical Trials on oxidized regenerated cellulose collagen-silver

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe