Nonrandomized Assessment of Ingrown ToenaiLs Treated by Excision of Skinfold Rather Than Toenail (NAILTEST)
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|ClinicalTrials.gov Identifier: NCT02067897|
Recruitment Status : Unknown
Verified November 2014 by Michael Livingston, Western University, Canada.
Recruitment status was: Enrolling by invitation
First Posted : February 20, 2014
Last Update Posted : November 13, 2014
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
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.
- Recurrence [ Time Frame: Up to 6 months after surgery ]Clinical signs of recurrence will be assessed 1 month, 2 months, and 6 months after surgery.
- Pain, functional status, and quality of life [ Time Frame: Baseline, 1 month, 2 months, 6 months after surgery ]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 ]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 ]Recovery time will be calculated in days off before returning to work, school, and normal footwear.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067897
|Children's Hospital of Western Ontario, London Health Sciences Centre|
|London, Ontario, Canada, N6A 5W9|
|Principal Investigator:||Sarah A Jones, MD, PhD, FRCSC||Division of Pediatric Surgery|