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Nonrandomized Assessment of Ingrown ToenaiLs Treated by Excision of Skinfold Rather Than Toenail (NAILTEST)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Michael Livingston, Western University, Canada
ClinicalTrials.gov Identifier:
NCT02067897
First received: February 12, 2014
Last updated: November 11, 2014
Last verified: November 2014
  Purpose

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.


Condition
Nails, Ingrown

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nonrandomized Assessment of Ingrown ToenaiLs Treated by Excision of Skinfold Rather Than Toenail (NAILTEST): a Study of the Vandenbos Procedure in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Western University, Canada:

Primary Outcome Measures:
  • Recurrence [ Time Frame: Up to 6 months after surgery ] [ Designated as safety issue: No ]
    Clinical signs of recurrence will be assessed 1 month, 2 months, and 6 months after surgery.


Secondary Outcome Measures:
  • Pain, functional status, and quality of life [ Time Frame: Baseline, 1 month, 2 months, 6 months after surgery ] [ Designated as safety issue: No ]
    Pain, functional status, and quality of life will be measured with the 5-item EuroQol-5D-5L.

  • Patient satisfaction [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    Patient satisfaction with the Vandenbos procedure will be measured with the 8-item Surgical Satisfaction Questionnaire (SSQ).

  • Recovery time [ Time Frame: 1 month, 2 months, 6 months after surgery ] [ Designated as safety issue: No ]
    Recovery time will be calculated in days off before returning to work, school, and normal footwear.


Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

Ingrown toenails are common among adolescents and young adults with the big toe being the most commonly affected. The exact incidence is unknown. An ingrown toenail occurs when the nail traumatizes the surrounding skin, resulting in swelling, infection, and the generation of granulation tissue. This cycle causes the nail to embed itself even further into the surrounding tissues, leading to additional swelling and infection.

Many treatments have been proposed for this condition. Non-surgical options include soaking, wearing loose shoes, antibiotics, and specialized braces. While these treatments often provide short-term symptomatic relief, many people with ingrown toenails eventually need surgery. The most common surgical treatment is a wedge excision (removal of the ingrown part of the nail). Most clinicians perform a partial matricectomy at the same time (destruction of part of the underlying nailbed with chemicals or surgical instruments). This prevents recurrence (where the toenail becomes ingrown again). The rate of recurrence with the wedge excision and matricectomy is reported to be 12-50%.

An alternative surgical technique is the Vandenbos procedure, where the skinfold is excised and allowed to heal by secondary intention over a period of approximately 6 weeks. This approach theoretically involves more pain, a higher risk of post-operative bleeding (because it is initially an open wound), and a longer recovery time. Proponents of this technique argue that these short-term morbidities are justified given the low rate of recurrence and excellent long-term results.

The original case series published by Vandenbos in 1959 found a recurrence rate of 0%. Two recent case series published by doctors from Ontario reported the same finding, but it was unclear how many patients in their series were lost to follow-up. Other studies have reported positive results but with a recurrence rate of 7-20%. Thus, the true effectiveness of this procedure remains unclear. Furthermore, there is no high quality evidence to support one technique over the other. Even a recent Cochrane review of 24 randomized controlled trials could not reach any definitive conclusions as to which procedure (among other surgical options) is the most effective. Previous trials show significant heterogeneity and none have assessed the Vandenbos procedure specifically. As a result, many clinicians continue to use the wedge excision and matricectomy.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to understand English
  • Severe medical co-morbidities
  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: NCT02067897

Locations
Canada, Ontario
Children's Hospital of Western Ontario, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Michael Livingston
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Sarah A Jones, MD, PhD, FRCSC Division of Pediatric Surgery
  More Information

Publications:
Responsible Party: Michael Livingston, Resident, Division of General Surgery, Western University, Canada
ClinicalTrials.gov Identifier: NCT02067897     History of Changes
Other Study ID Numbers: 104906
Study First Received: February 12, 2014
Last Updated: November 11, 2014
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by Western University, Canada:
Nails, Ingrown
Children
Ambulatory Surgical Procedures

Additional relevant MeSH terms:
Nails, Ingrown
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014