NCT02067897

Brief Summary

Ingrown toenails occur when the nail grows into the surrounding skin, resulting in pain and infection. The most common procedure to treat this problem is a wedge excision (removal of part of the toenail) and matricectomy (destruction of part of the nailbed with chemicals or surgical instruments). This study will evaluate the effectiveness of an alternative technique called the Vandenbos procedure (where the skin is removed and the toenail is left intact). This procedure is currently being used by some of the pediatric surgeons at our hospital and we want to evaluate our results up to 6 months after surgery. We believe that the true recurrence rate will be greater than 0% but that recovery time and morbidity will be acceptable to most patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 13, 2014

Status Verified

November 1, 2014

Enrollment Period

2 years

First QC Date

February 12, 2014

Last Update Submit

November 11, 2014

Conditions

Nails, Ingrown

Keywords

Nails, IngrownChildrenAmbulatory Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Clinical signs of recurrence will be assessed 1 month, 2 months, and 6 months after surgery.

    Up to 6 months after surgery

Secondary Outcomes (3)

  • Pain, functional status, and quality of life

    Baseline, 1 month, 2 months, 6 months after surgery

  • Patient satisfaction

    6 months after surgery

  • Recovery time

    1 month, 2 months, 6 months after surgery

Study Arms (1)

Vandenbos procedure (skinfold excision)

Participants in this cohort will undergo with Vandenbos procedure (skinfold excision) for one or more ingrown toenails. This surgery will be formed as an day procedure under general anesthetic.

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population include children and adolescents aged 10 to 18 years with one or more ingrown toenails. They may have undergone previous surgical and/or non-surgical treatment for this condition.

You may qualify if:

  • to 18 years old
  • Undergoing Vandenbos procedure for one or more ingrown toenails
  • Willing to complete assessments

You may not qualify if:

  • Inability to understand English
  • Severe medical co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Western Ontario, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (9)

  • Yang G, Yanchar NL, Lo AY, Jones SA. Treatment of ingrown toenails in the pediatric population. J Pediatr Surg. 2008 May;43(5):931-5. doi: 10.1016/j.jpedsurg.2007.12.042.

    PMID: 18485969BACKGROUND

  • Heidelbaugh JJ, Lee H. Management of the ingrown toenail. Am Fam Physician. 2009 Feb 15;79(4):303-8.

    PMID: 19235497BACKGROUND

  • Eekhof JA, Van Wijk B, Knuistingh Neven A, van der Wouden JC. Interventions for ingrowing toenails. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD001541. doi: 10.1002/14651858.CD001541.pub3.

    PMID: 22513901BACKGROUND

  • Vandenbos KQ, Bowers WF. Ingrown toenail: a result of weight bearing on soft tissue. U S Arm Forces Med J 1959;10:1168-73.

    BACKGROUND

  • Chapeskie H, Kovac JR. Case Series: Soft-tissue nail-fold excision: a definitive treatment for ingrown toenails. Can J Surg. 2010 Aug;53(4):282-6.

    PMID: 20646404BACKGROUND

  • Haricharan RN, Masquijo J, Bettolli M. Nail-fold excision for the treatment of ingrown toenail in children. J Pediatr. 2013 Feb;162(2):398-402. doi: 10.1016/j.jpeds.2012.07.056. Epub 2012 Sep 10.

    PMID: 22974574BACKGROUND

  • Antrum RM. Radical excision of the nailfold for ingrowing toenail. J Bone Joint Surg Br. 1984 Jan;66(1):63-5. doi: 10.1302/0301-620X.66B1.6693479.

    PMID: 6693479BACKGROUND

  • Persichetti P, Simone P, Li Vecchi G, Di Lella F, Cagli B, Marangi GF. Wedge excision of the nail fold in the treatment of ingrown toenail. Ann Plast Surg. 2004 Jun;52(6):617-20. doi: 10.1097/01.sap.0000095436.08812.67.

    PMID: 15167000BACKGROUND

  • Mitchell S, Jackson CR, Wilson-Storey D. Surgical treatment of ingrown toenails in children: what is best practice? Ann R Coll Surg Engl. 2011 Mar;93(2):99-102. doi: 10.1308/003588411X12851639107674. Epub 2010 Nov 12.

    PMID: 21073822BACKGROUND

MeSH Terms

Conditions

Nails, Ingrown

Condition Hierarchy (Ancestors)

Nail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sarah A Jones, MD, PhD, FRCSC

    Division of Pediatric Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident, Division of General Surgery

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 20, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 13, 2014

Record last verified: 2014-11

Locations

CA(1)